Hodgkin DiseasePhase 1NCT02663297
Administration of T Lymphocytes for Prevention of Relapse of Lymphomas
A Phase 1 study testing ATLCAR.CD30 cells in people with Hodgkin Disease and Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin
- What is being tested?
- ATLCAR.CD30 cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2016to 25 Jan 2037
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent.
- 3 to 17 years of age for pediatric patients, ≥18 years of age for adults; NOTE: children will not be allowed to enroll in a dose cohort until a minimum of 2 adult subjects are enrolled and complete their DLT assessment follow-up at that dose level
- Diagnosis of recurrent HL with a treatment plan that will include high dose chemotherapy with/without total body irradiation and autologous cell transplantation
- NHL patients with ALK negative CD30+ anaplastic large-cell lymphomas, CD30+ ALCL regardless of ALK status, with chemotherapy-sensitive relapse, CD30+ high-risk DLBCL, CD30+ cutaneous T cell lymphoma, or CD30+ mycosis fungoides who are otherwise eligible for transplant, are eligible for this study
- CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with ATLCAR.CD30 cells); NOTE: CD30 + disease is defined as requiring documentation of CD30 expression by immunohistochemistry based on the institutional hematopathology standard.
- Evidence of adequate organ function as defined by:
Show all 26Show fewer
- The following is required prior to procurement (NOTE: labs do not need to be redrawn if they have already been performed as part of SOC pre-transplant work-up; Subject must be eligible to receive ASCT)
- Hgb ≥ 8.0g/dL
- Bilirubin ≤1.5 times the upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Serum creatinine ≤1.5 times ULN
- Cardiac and pulmonary function that is adequate for ASCT
- The following is required prior to infusion of ATLCAR.CD30 cells:
- Absolute neutrophil count (ANC) ≥500 cells/mm^3 for 3 consecutive days; Note: ANC may be measured at the beginning and the end of a time frame expanding at least 3 days and does not need to be evaluated on each individual day AND
- Platelet count ≥25,000 cells/mm^3 without transfusion over preceding 5 days Note: Platelets may be measured at the beginning and the end of a time frame expanding at least 5 days and does not need to be evaluated on each individual day AND
- Hg ≥8g/dL without transfusion support over preceding 5 days Note: Hg may be measured at the beginning and the end of a time frame expanding at least 3 days and does not need to be evaluated on each individual day
- Bilirubin ≤1.5 times the upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Serum creatinine ≤1.5 times ULN
- Pulse oximetry of > 90% on room air
- Imaging results from within 60 days prior to transplant (used as baseline measure for documentation of disease status). Note: Results may be obtained at a time point greater than 30 days from transplant if obtained per the patient's standard of care and with prior sponsor approval.
- Negative serum pregnancy test within 72 hours prior to procurement and again 72 hours prior to infusion
- Karnofsky or Lansky score of > 60%
- Considered at high risk for relapse as defined by: The presence of ≥ 1 of the following: failure to achieve CR post initial treatment; relapsed disease with an initial remission duration of <12 months; or extranodal involvement at the start of pre-transplant salvage therapy
- Subjects must have autologous transduced activated T cells that meet the Certificate of Analysis (CoA) acceptance criteria
- Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The male partner of WOCBP subjects enrolled into the trial should be instructed to use a condom by their female partner enrolled in the trial.
Who cannot join
- Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion.
- Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion
- History of hypersensitivity reactions to murine protein-containing products
- Pregnant or lactating
- Tumor in a location where enlargement could cause airway obstruction.
- Current use of systemic corticosteroids at doses ≥10mg/day prednisone or its equivalent; those receiving <10mg/day may be enrolled at discretion of investigator
- Active infection with HIV, HTLV, HBV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) . Active infection is defined as not being well controlled on therapy (Note: To meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV1 and 2 antibody, negative for Hepatitis B surface antigen, or negative for HCV antibody or HCV viral load).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas After High Dose Therapy and Autologous Stem Transplantation (ATLAS)
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been sufficient to cure most patients. This study is designed to combine both T cells and antibodies to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.
In previous studies, it has been shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying the patient's genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD30. This antibody floats around in the blood and can detect and stick to cancer cells called lymphoma cells because they have a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. Only the part of the antibody that sticks to the lymphoma cells is attached to the T cells instead of the entire antibody. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.
The purpose of this research study is to determine a safe dose of the ATLCAR.CD30 cells that can be given to subjects after undergoing an autologous transplant. This is the first step in determining whether giving ATLCAR.CD30 cells to others with lymphoma in the future will help them. The researchers also want to find out what side effects patients will have after they receive the ATLCAR.CD30 cells post-transplant. This study will also look at other effects of ATLCAR.CD30 cells, including their effect on your cancer and how long they will survive in your body.
Read the detailed description
STUDY OBJECTIVES
Primary Objective
- To determine the safety and tolerability and to estimate the MTD of ATLCAR.CD30 post ASCT in patients with CD30+ lymphoma at high risk for relapse
Secondary Objectives
- To measure the survival of ATLCAR.CD30 in vivo
- To estimate PFS after infusion of ATLCAR.CD30 post ASCT in patients with CD30+ lymphoma at high risk for relapse
- To determine the overall survival after infusion of ATLCAR.CD30 post ASCT in patients with CD30+ lymphoma at high risk for relapse
Exploratory Objective
- To measure patient-reported symptom, physical function, and health-related quality of life at baseline and over time in patients treated with ATLCAR.CD30 cells.
ENDPOINTS
Primary Endpoint
- Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) and CRS toxicity will be graded according to the toxicity scale outlined in 11.6 (Appendix F: CRS Toxicity Grading Scale and Management Guidelines). The MTD will be based on the rate of dose-limiting toxicity
Secondary (Clinical) Endpoint
- PFS is defined from day of ASCT to relapse (in subjects with a documented complete response after ASCT) or progression (in subjects with documented stable disease or partial response after ASCT), or death as a result of any cause as per the Revised Response Criteria for Malignant Lymphoma.
- Overall survival will be measured from the date of administration of CAR.CD30 transduced ATL to date of death
- Persistence of CAR.CD30 T cells in vivo will be determined by quantitative PCR and flow cytometry in peripheral blood samples.
Exploratory Endpoint
- Patient reported symptoms will be measured using selected symptoms from the NCI PRO-CTCAE. Patient-reported physical function will be measured using the PROMIS Physical Function Score derived from the PROMIS Physical Function Short Form 20a v1.0. Patient-reported health-related quality of life will be measured using the PROMIS Global Health Score derived from the PROMIS Global Health Short Form v1.0-1.1.
OUTLINE
Patients scheduled to undergo an autologous stem cell transplantation (ASCT) for treatment of lymphoma will be approached for consent to screening and potential enrollment into LCCC1524. Peripheral blood cells will be collected from consenting patients who meet eligibility for cell procurement for creation of ATLCAR.CD30 cells prior to ASCT. The ASCT, including mobilization and collection of PBSCs, administration of myeloablative therapy, reinfusion of PBSCs and supportive care following transplant will be as per routine standard of care, and not expected to be impacted by enrollment into LCCC1524. Post ASCT, patients who meet eligibility criteria for treatment will receive one infusion of ATLCAR.CD30 cells once there is evidence of hematologic recovery. Research personnel will keep track of any patients who undergo procurement but do not undergo treatment with ATLCAR.CD30 cells, and the reason for withholding treatment.
Cell Procurement
Peripheral blood, up to 300 mL total (in up to 3 collections) will be obtained for subjects for cell procurement. In patients with low (CD3 count as assayed by flow cytometry less than 200/μl) T-cell count in the peripheral blood, a leukopheresis may be performed to isolate sufficient T cells. The parameters for pheresis will be up to 2 blood volumes.
For pediatric patients (patients under 18 years of age), the total amount of blood drawn will not be more than 3 mL (less than 1 teaspoon per 2.2 lbs. that the child weighs.
ATLCAR.CD30 Cells Administration
Post ASCT, once the patient has started to experience hematologic recovery (defined as ANC ≥500 cells/mm3 for 3 consecutive days, AND platelet count ≥25 cells/mm3 without transfusion over the preceding 5 days, AND Hg ≥8g/dL without transfusion support over preceding 5 days), ATLCAR.CD30 cells will be admnistered. This will generally occur between 14 and 20 days following infusion of autologous stem cells following high-dose chemotherapy.
Duration of Therapy
Therapy in LCCC1524 involves just one infusion of ATLCAR.CD30 cells. Treatment with one infusion will be administered unless:
- Patient decides to withdraw from study treatment, OR
- General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Duration of Follow-Up
Patients will be followed for up to 15 years or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
- Conditions
- Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin, Immune System Diseases, Immunoproliferative Disorders, Lymphatic Diseases
- Being tested
- ATLCAR.CD30 cells
- Keywords
- CAR T cells, CD30, Lymphoma, T Lymphocytes
- Medical subject headings
- Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin, Immune System Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLCAR.CD30 cellsDrug
Also called CAR.CD30 T cells
Three dose levels will be evaluated:
Group One, 2x10^7 cells/m^2 (maximum dose 5x10^7 cells)
Group Two, 1x10^8 cells/m^2 (maximum dose 2.5x10^8 cells)
Group Three, 2x10^8 cells/m^2 (maximum dose 5x10^8 cells)
| Study group | Role | What they receive |
|---|---|---|
| ATLCAR.CD30 cells | Experimental | Three dose levels of ATLCAR.CD30 cells will be evaluated. Using the modified continual reassessment method (CRM), initial cohort of size two will be enrolled at each dose level after that subjects are enrolled one at a time until a minimum of 12 patients is treated. Each patient will receive one injection according to the dosing schedules listed below. Investigators will start with the lowest cell dose (2X10^7 cells/m^2) given to patients in one of our previous trials employing CAR-T cells including the CD28 costimulatory endodomain, and investigators will escalate the cell dose to the highest cell dose (2X10^8/m^2) given in the same trial.
Note: Initially, only adults will be enrolled during the dose escalation phase of the study. Once a dose level has been tested in at least 2 adults without the occurrence of dose limiting toxicities (DLTs), children may then be enrolled on that dose level according to the CRM. Receives: Drug: ATLCAR.CD30 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Escalating Doses of Autologous Activated T Lymphocytes
The Maximum tolerated dose was based on the rate of dose-limiting toxicity. Toxicity was classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0), and cytokine release syndrome (CRS). The number of subjects with dose-limiting toxicity was recorded.CTCAE Grade 1 Mild, Grade 2 Moderate, Grade 3, Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Cytokine Release Syndrome (CRS) will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild Grade 2 - Moderate, Grade 3 - Severe (Aggressive Intervention): Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38oC, Hypotension requiring multiple vasopressors, Hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
Measured: 6 weeks
Secondary outcomes (3)
To Measure the Survival of ATLCAR.CD30 in Vivo
Persistence of CAR.CD30 T cells in vivo will be determined by quantitative polymerase chain reaction (PCR) and flow cytometry in peripheral blood samples
Measured: 15 years
To Estimate PFS After Infusion of ATLCAR.CD30 Post ASCT in Patients With CD30+ Lymphoma at High Risk for Relapse
PFS is defined from day of ASCT to relapse (in subjects with a documented complete response after ASCT) or progression (in subjects with documented stable disease or partial response after ASCT), or death as a result of any cause as per the Revised Response Criteria for Malignant Lymphoma
Measured: 15 years
Determine the Overall Survival After Infusion of ATLCAR.CD30
Overall survival will be measured from the date of administration of CAR.CD30 transduced ATL to date of death
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start7 Jun 2016
- Primary completion15 Jan 2021
- Study completion25 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Natalie Grover, MD, Principal investigator, Clinical Director of Cellular Therapy Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663297
- Sponsor's protocol ID
- LCCC 1524-ATL
- Other IDs
- R01HL114564
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2016
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grover NS, Hucks G, Riches ML, Ivanova A, Moore DT, Shea TC, Seegars MB, Armistead PM, Kasow KA, Beaven AW, Dittus C, Coghill JM, Jamieson KJ, Vincent BG, Wood WA, Cheng C, Morrison JK, West J, Cavallo T, Dotti G, Serody JS, Savoldo B. Anti-CD30 CAR T cells as consolidation after autologous haematopoietic stem-cell transplantation in patients with high-risk CD30+ lymphoma: a phase 1 study. Lancet Haematol. 2024 May;11(5):e358-e367. doi: 10.1016/S2352-3026(24)00064-4. Epub 2024 Mar 28.
PubMed 38555923
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas After High Dose Therapy and Autologous Stem Transplantation (ATLAS)
- ClinicalTrials.gov ID
- NCT02663297
- Acronym / sponsor ID
- LCCC 1524-ATL
- Conditions
- Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin, Immune System Diseases, Immunoproliferative Disorders, Lymphatic Diseases
- Keywords
- CAR T cells, CD30, Lymphoma, T Lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 25 Jan 2037 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been sufficient to cure most patients. This study is designed to combine both T cells and antibodies to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.
In previous studies, it has been shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying the patient's genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD30. This antibody floats around in the blood and can detect and stick to cancer cells called lymphoma cells because they have a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. Only the part of the antibody that sticks to the lymphoma cells is attached to the T cells instead of the entire antibody. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.
The purpose of this research study is to determine a safe dose of the ATLCAR.CD30 cells that can be given to subjects after undergoing an autologous transplant. This is the first step in determining whether giving ATLCAR.CD30 cells to others with lymphoma in the future will help them. The researchers also want to find out what side effects patients will have after they receive the ATLCAR.CD30 cells post-transplant. This study will also look at other effects of ATLCAR.CD30 cells, including their effect on your cancer and how long they will survive in your body.
Detailed description
STUDY OBJECTIVES
Primary Objective
- To determine the safety and tolerability and to estimate the MTD of ATLCAR.CD30 post ASCT in patients with CD30+ lymphoma at high risk for relapse
Secondary Objectives
- To measure the survival of ATLCAR.CD30 in vivo
- To estimate PFS after infusion of ATLCAR.CD30 post ASCT in patients with CD30+ lymphoma at high risk for relapse
- To determine the overall survival after infusion of ATLCAR.CD30 post ASCT in patients with CD30+ lymphoma at high risk for relapse
Exploratory Objective
- To measure patient-reported symptom, physical function, and health-related quality of life at baseline and over time in patients treated with ATLCAR.CD30 cells.
ENDPOINTS
Primary Endpoint
- Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) and CRS toxicity will be graded according to the toxicity scale outlined in 11.6 (Appendix F: CRS Toxicity Grading Scale and Management Guidelines). The MTD will be based on the rate of dose-limiting toxicity
Secondary (Clinical) Endpoint
- PFS is defined from day of ASCT to relapse (in subjects with a documented complete response after ASCT) or progression (in subjects with documented stable disease or partial response after ASCT), or death as a result of any cause as per the Revised Response Criteria for Malignant Lymphoma.
- Overall survival will be measured from the date of administration of CAR.CD30 transduced ATL to date of death
- Persistence of CAR.CD30 T cells in vivo will be determined by quantitative PCR and flow cytometry in peripheral blood samples.
Exploratory Endpoint
- Patient reported symptoms will be measured using selected symptoms from the NCI PRO-CTCAE. Patient-reported physical function will be measured using the PROMIS Physical Function Score derived from the PROMIS Physical Function Short Form 20a v1.0. Patient-reported health-related quality of life will be measured using the PROMIS Global Health Score derived from the PROMIS Global Health Short Form v1.0-1.1.
OUTLINE
Patients scheduled to undergo an autologous stem cell transplantation (ASCT) for treatment of lymphoma will be approached for consent to screening and potential enrollment into LCCC1524. Peripheral blood cells will be collected from consenting patients who meet eligibility for cell procurement for creation of ATLCAR.CD30 cells prior to ASCT. The ASCT, including mobilization and collection of PBSCs, administration of myeloablative therapy, reinfusion of PBSCs and supportive care following transplant will be as per routine standard of care, and not expected to be impacted by enrollment into LCCC1524. Post ASCT, patients who meet eligibility criteria for treatment will receive one infusion of ATLCAR.CD30 cells once there is evidence of hematologic recovery. Research personnel will keep track of any patients who undergo procurement but do not undergo treatment with ATLCAR.CD30 cells, and the reason for withholding treatment.
Cell Procurement
Peripheral blood, up to 300 mL total (in up to 3 collections) will be obtained for subjects for cell procurement. In patients with low (CD3 count as assayed by flow cytometry less than 200/μl) T-cell count in the peripheral blood, a leukopheresis may be performed to isolate sufficient T cells. The parameters for pheresis will be up to 2 blood volumes.
For pediatric patients (patients under 18 years of age), the total amount of blood drawn will not be more than 3 mL (less than 1 teaspoon per 2.2 lbs. that the child weighs.
ATLCAR.CD30 Cells Administration
Post ASCT, once the patient has started to experience hematologic recovery (defined as ANC ≥500 cells/mm3 for 3 consecutive days, AND platelet count ≥25 cells/mm3 without transfusion over the preceding 5 days, AND Hg ≥8g/dL without transfusion support over preceding 5 days), ATLCAR.CD30 cells will be admnistered. This will generally occur between 14 and 20 days following infusion of autologous stem cells following high-dose chemotherapy.
Duration of Therapy
Therapy in LCCC1524 involves just one infusion of ATLCAR.CD30 cells. Treatment with one infusion will be administered unless:
- Patient decides to withdraw from study treatment, OR
- General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Duration of Follow-Up
Patients will be followed for up to 15 years or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATLCAR.CD30 cells | Experimental | Drug: ATLCAR.CD30 cellsThree dose levels of ATLCAR.CD30 cells will be evaluated. Using the modified continual reassessment method (CRM), initial cohort of size two will be enrolled at each dose level after that subjects are enrolled one at a time until a minimum of 12 patients is treated. Each patient will receive one injection according to the dosing schedules listed below. Investigators will start with the lowest cell dose (2X10^7 cells/m^2) given to patients in one of our previous trials employing CAR-T cells including the CD28 costimulatory endodomain, and investigators will escalate the cell dose to the highest cell dose (2X10^8/m^2) given in the same trial. Note: Initially, only adults will be enrolled during the dose escalation phase of the study. Once a dose level has been tested in at least 2 adults without the occurrence of dose limiting toxicities (DLTs), children may then be enrolled on that dose level according to the CRM. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent.
- 3 to 17 years of age for pediatric patients, ≥18 years of age for adults; NOTE: children will not be allowed to enroll in a dose cohort until a minimum of 2 adult subjects are enrolled and complete their DLT assessment follow-up at that dose level
- Diagnosis of recurrent HL with a treatment plan that will include high dose chemotherapy with/without total body irradiation and autologous cell transplantation
- NHL patients with ALK negative CD30+ anaplastic large-cell lymphomas, CD30+ ALCL regardless of ALK status, with chemotherapy-sensitive relapse, CD30+ high-risk DLBCL, CD30+ cutaneous T cell lymphoma, or CD30+ mycosis fungoides who are otherwise eligible for transplant, are eligible for this study
- CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with ATLCAR.CD30 cells); NOTE: CD30 + disease is defined as requiring documentation of CD30 expression by immunohistochemistry based on the institutional hematopathology standard.
Key exclusion criteria (7 listed)
- Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion.
- Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion
- History of hypersensitivity reactions to murine protein-containing products
- Pregnant or lactating
- Tumor in a location where enlargement could cause airway obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATLCAR.CD30 cellsAlso: CAR.CD30 T cellsThree dose levels will be evaluated: Group One, 2x10^7 cells/m^2 (maximum dose 5x10^7 cells) Group Two, 1x10^8 cells/m^2 (maximum dose 2.5x10^8 cells) Group Three, 2x10^8 cells/m^2 (maximum dose 5x10^8 cells) | Drug | ATLCAR.CD30 cells |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Escalating Doses of Autologous Activated T Lymphocytes
Time frame: 6 weeks
The Maximum tolerated dose was based on the rate of dose-limiting toxicity. Toxicity was classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0), and cytokine release syndrome (CRS). The number of subjects with dose-limiting toxicity was recorded.CTCAE Grade 1 Mild, Grade 2 Moderate, Grade 3, Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Cytokine Release Syndrome (CRS) will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild Grade 2 - Moderate, Grade 3 - Severe (Aggressive Intervention): Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38oC, Hypotension requiring multiple vasopressors, Hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
3 secondary outcomes
To Measure the Survival of ATLCAR.CD30 in Vivo
Time frame: 15 years
To Estimate PFS After Infusion of ATLCAR.CD30 Post ASCT in Patients With CD30+ Lymphoma at High Risk for Relapse
Time frame: 15 years
Determine the Overall Survival After Infusion of ATLCAR.CD30
Time frame: 15 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38555923Grover NS, Hucks G, Riches ML, Ivanova A, Moore DT, Shea TC, Seegars MB, Armistead PM, Kasow KA, Beaven AW, Dittus C, Coghill JM, Jamieson KJ, Vincent BG, Wood WA, Cheng C, Morrison JK, West J, Cavallo T, Dotti G, Serody JS, Savoldo B. Anti-CD30 CAR T cells as consolidation after autologous haematopoietic stem-cell transplantation in patients with high-risk CD30+ lymphoma: a phase 1 study. Lancet Haematol. 2024 May;11(5):e358-e367. doi: 10.1016/S2352-3026(24)00064-4. Epub 2024 Mar 28.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Grover, MD principal investigator
Clinical Director of Cellular Therapy Program
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATLCAR.CD30 cells in people with Hodgkin Disease and Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Escalating Doses of Autologous Activated T Lymphocytes (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.