Germ Cell TumorPhase 2NCT05634785
CD30 CAR for CD30+ NSGCT
A Phase 2 study testing ATLCAR.CD30 Cells, Cyclophosphamid and Fludarabine in people with Germ Cell Tumor and Nonseminomatous Germ Cell Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a phase 2 research study that enrolls adult subjects with Nonseminomatous Germ Cell Tumors (NSGCT). The purpose of this study is to create a repository and explore the presence of modified T cells in the subject's plasma or tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Germ Cell Tumor, Nonseminomatous Germ Cell Tumor
- What is being tested?
- ATLCAR.CD30 Cells, Cyclophosphamid and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2022to 18 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.
- Age ≥ 18 years at the time of consent.
- Histologically confirmed diagnosis of Nonseminomatous Germ Cell Tumors (NSGCT) of any primary site.
- Subjects must have received at least one prior line of therapy for their NSGCT and meet one of the following criteria. There is no maximum number of prior lines of treatment allowed.
- Evidence of progressive or recurrent NSGCT after prior high-dose chemotherapy (HDCT) treatment, defined as meeting at least one of the following criteria: i. Tumor biopsy of new or growing or unresectable lesions demonstrating viable NSGCT. In the event of an incomplete gross resection where viable NSGCT is found, subjects will be considered eligible for the study. ii. Consecutive elevated serum tumor markers (β-HCG or AFP) are increasing. An increase of elevated lactate dehydrogenase (LDH) alone does not constitute progressive disease. iii. Development of new or enlarging lesions in the setting of persistently elevated β-HCG or AFP, even if the β-HCG and AFP are not continuing to rise.
Who cannot join
- Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated in the study).
- Active infection with HIV, human T-cell leukemia virus, hepatitis B virus, and hepatitis C virus (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Note: To meet eligibility subjects are required to be negative for HIV antibody, negative for HTLV1 and 2 antibodies or PCR negative for HTLV1 and 2, negative for Hepatitis B surface antigen, and negative for HCV antibody or HCV viral load.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Patients With CD30+ Nonseminomatous Germ Cell Tumors (NSGCT)
This is a phase 2 research study that enrolls adult subjects with Nonseminomatous Germ Cell Tumors (NSGCT). The purpose of this study is to create a repository and explore the presence of modified T cells in the subject's plasma or tumors.
This study collects biospecimens (such as tumor tissue, blood, and modified T cells) that can be used in future research studies. The collected specimens can help to examine whether the modified T cells are present in the body and tumor. If the modified T cells are present in the body, and how long they last. They also will use the specimen to identify ways to improve treatment options for a future cancer patient.
Read more
Research with blood, tissue, or body fluids (specimens) can help researchers understand how the human body works. Sometimes researchers collect and store specimens and use them for different kinds of research or share them with other scientists; this is called a specimen repository or "biobank." Research with biospecimens might help to introduce new tests to find diseases or new ways to treat diseases.
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 called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.
Prior trials have shown the safety of ATLCAR.CD30 product was administered to subjects with lymphomas. This study was planned based on the safety and efficacy data from previous studies (NCT02690545 and NCT02917083).
- Conditions
- Germ Cell Tumor, Nonseminomatous Germ Cell Tumor
- Being tested
- ATLCAR.CD30 Cells, Cyclophosphamid, Fludarabine
- Keywords
- cellular therapy, modified T cells, ATLCAR.CD30, biobank, repository, specimen
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Nonseminomatous germ cell tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLCAR.CD30 CellsBiological
Also called CAR.CD30 T cells
The cellular product consists of ATLCAR.CD30 cells will be administered via intravenous injection, over 5 - 10 minutes after lymphodepletion. The expected volume will be 1 - 50 mL, the prescribed dose will be 2 × 108 CAR-T cells per meter square and the maximum dose will be 5 × 108 CAR-T cells per meter square.
CyclophosphamidDrug
Also called Cytoxan
Two to 14 days prior to the initial ATLCAR.CD30 infusion, subjects will receive a lymphodepletion regimen that includes 300 mg per square meter of intravenous cyclophosphamide.
FludarabineDrug
Also called Fludara
Two to 14 days prior to the initial ATLCAR.CD30 infusion, subjects will receive a lymphodepletion regimen that includes daily 30 mg per square meter of intravenous fludarabine infusion for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| ATLCAR.CD30 | Experimental | Single Group Assignment: Subjects with Nonseminomatous Germ Cell Tumors who meet eligibility criteria for cellular therapy. Receives: Biological: ATLCAR.CD30 Cells; Drug: Cyclophosphamid; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall response rate (ORR)- Response Evaluation Criteria In Solid Tumors Criteria (RECIST)
ORR - RECIST will be assessed per RECIST v1.1. criteria which define Complete Response (CR) as the disappearance of all target lesions, pathological lymph node (LN) <10mm, and normalization of serum tumor markers; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions serum tumor markers (AFP and β-hCG) should be stable or decreasing. ; and Overall Response Rate (ORR) = CR + PR/total number of subjects.
Measured: 6 weeks
Secondary outcomes (11)
The Overall response rate (ORR)- Per immune-related Response Evaluation Criteria (irRECIST)
ORR -irRECIST will be assessed per irRECIST criteria which defines complete response (irCR), the disappearance of all lesions, no new lesions, lymph nodes < 10 mm in short axis; partial response (irPR), ≥30% decrease in the sum of target lesions and non-target lesions are irNN; Stable response (irSD), not meeting criteria for irCR, irPR, or irPD; Progressive Disease (irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir; for no new non-target or (irNN) and where irPR or irPD are confirmed by a repeat, consecutive assessment.
Measured: Up to 6 weeks
The best overall response rate (BORR)
BORR will be defined as the best response recorded after the administration of the cell therapy to the date of disease progression per modified RECIST 1.1, or death as a result of any cause.
Measured: Up to 6 weeks
Progression free survival (PFS)
PFS will be defined per modified RECIST 1.1 criteria. PFS is defined from the day of ATLCAR.CD30 infusion to relapse (in patients with a documented complete response at the time of cell infusion) or progression (in patients without a complete response at the time of cell infusion), or death as a result of any cause per modified RECIST 1.1 criteria classification.
Measured: Up to12 weeks
Median Progression free survival (PFS)
Median PFS is defined from the day of initial lymphodepletion administration of the first ATLCAR.CD30 product infusion to the date of disease progression per modified RECIST 1.1 criteria or death as a result of any cause.
Measured: Up to12 weeks
Duration of response (DOR)
DOR will be defined as the time from documentation of PR or better to PD as defined by modified RECIST 1.1 criteria. Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter (LD) of the target lesions, a relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm or the appearance of one or more new lesion or unequivocal progression of non-target or non-measurable lesions (e.g. worsening bone pain requiring radiation or significant increase in pain medications) or increase ≥ 50% in AFP or β-hCG.
Measured: Up to12 weeks
The percentage of improvement
The percentage of subjects who have an improvement in their response per modified RECIST 1.1.
Measured: Up to 12 weeks
Adverse Events CTCAE
Adverse Events CTCAE will be classified and graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: Up to 6 weeks
Cytokine Release Syndrome (CRS)
Cytokine Release Syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild (Symptomatic Management): Fever ≥38oC, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38oC, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe (Aggressive Intervention): Fever ≥38oC , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g., continuous positive airway pressure (CPAP), BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
Measured: Up to 6 weeks
Immune effector cell-associated neurotoxicity syndrome (ICANS)
Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).
Measured: Up to 6 weeks
Overall survival
Overall survival will be defined from the day of initial lymphodepletion for the first administration ATLCAR.CD30 cells to date of death.
Measured: Up to 5 years
Persistence and expansion of ATLCAR.CD30
Persistence and expansion of ATLCAR.CD30 in peripheral blood will be determined by quantitative polymerase chain reaction (qPCR) and flow cytometry in the sample of peripheral blood.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start9 Dec 2022
- Primary completion16 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew I Milowsky, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634785
- Sponsor's protocol ID
- LCCC2048-ATL
- Status last verified
- Jul 2026
- First submitted
- 22 Nov 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Patients With CD30+ Nonseminomatous Germ Cell Tumors (NSGCT)
- ClinicalTrials.gov ID
- NCT05634785
- Acronym / sponsor ID
- LCCC2048-ATL
- Conditions
- Germ Cell Tumor, Nonseminomatous Germ Cell Tumor
- Keywords
- cellular therapy, modified T cells, ATLCAR.CD30, biobank, repository, specimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 research study that enrolls adult subjects with Nonseminomatous Germ Cell Tumors (NSGCT). The purpose of this study is to create a repository and explore the presence of modified T cells in the subject's plasma or tumors.
This study collects biospecimens (such as tumor tissue, blood, and modified T cells) that can be used in future research studies. The collected specimens can help to examine whether the modified T cells are present in the body and tumor. If the modified T cells are present in the body, and how long they last. They also will use the specimen to identify ways to improve treatment options for a future cancer patient.
Research with blood, tissue, or body fluids (specimens) can help researchers understand how the human body works. Sometimes researchers collect and store specimens and use them for different kinds of research or share them with other scientists; this is called a specimen repository or "biobank." Research with biospecimens might help to introduce new tests to find diseases or new ways to treat diseases.
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 called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.
Prior trials have shown the safety of ATLCAR.CD30 product was administered to subjects with lymphomas. This study was planned based on the safety and efficacy data from previous studies (NCT02690545 and NCT02917083).
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 | Experimental | Biological: ATLCAR.CD30 Cells, Drug: Cyclophosphamid, Drug: FludarabineSingle Group Assignment: Subjects with Nonseminomatous Germ Cell Tumors who meet eligibility criteria for cellular therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.
- Age ≥ 18 years at the time of consent.
- Histologically confirmed diagnosis of Nonseminomatous Germ Cell Tumors (NSGCT) of any primary site.
- Subjects must have received at least one prior line of therapy for their NSGCT and meet one of the following criteria. There is no maximum number of prior lines of treatment allowed.
- Evidence of progressive or recurrent NSGCT after prior high-dose chemotherapy (HDCT) treatment, defined as meeting at least one of the following criteria: i. Tumor biopsy of new or growing or unresectable lesions demonstrating viable NSGCT. In the event of an incomplete gross resection where viable NSGCT is found, subjects will be considered eligible for the study. ii. Consecutive elevated serum tumor markers (β-HCG or AFP) are increasing. An increase of elevated lactate dehydrogenase (LDH) alone does not constitute progressive disease. iii. Development of new or enlarging lesions in the setting of persistently elevated β-HCG or AFP, even if the β-HCG and AFP are not continuing to rise.
Key exclusion criteria (2 listed)
- Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated in the study).
- Active infection with HIV, human T-cell leukemia virus, hepatitis B virus, and hepatitis C virus (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Note: To meet eligibility subjects are required to be negative for HIV antibody, negative for HTLV1 and 2 antibodies or PCR negative for HTLV1 and 2, negative for Hepatitis B surface antigen, and negative for HCV antibody or HCV viral load.
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 cellsThe cellular product consists of ATLCAR.CD30 cells will be administered via intravenous injection, over 5 - 10 minutes after lymphodepletion. The expected volume will be 1 - 50 mL, the prescribed dose will be 2 × 108 CAR-T cells per meter square and the maximum dose will be 5 × 108 CAR-T cells per meter square. | Biological | ATLCAR.CD30 |
| CyclophosphamidAlso: CytoxanTwo to 14 days prior to the initial ATLCAR.CD30 infusion, subjects will receive a lymphodepletion regimen that includes 300 mg per square meter of intravenous cyclophosphamide. | Drug | ATLCAR.CD30 |
| FludarabineAlso: FludaraTwo to 14 days prior to the initial ATLCAR.CD30 infusion, subjects will receive a lymphodepletion regimen that includes daily 30 mg per square meter of intravenous fludarabine infusion for 3 days. | Drug | ATLCAR.CD30 |
Primary outcome
The Overall response rate (ORR)- Response Evaluation Criteria In Solid Tumors Criteria (RECIST)
Time frame: 6 weeks
ORR - RECIST will be assessed per RECIST v1.1. criteria which define Complete Response (CR) as the disappearance of all target lesions, pathological lymph node (LN) <10mm, and normalization of serum tumor markers; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions serum tumor markers (AFP and β-hCG) should be stable or decreasing. ; and Overall Response Rate (ORR) = CR + PR/total number of subjects.
11 secondary outcomes
The Overall response rate (ORR)- Per immune-related Response Evaluation Criteria (irRECIST)
Time frame: Up to 6 weeks
The best overall response rate (BORR)
Time frame: Up to 6 weeks
Progression free survival (PFS)
Time frame: Up to12 weeks
Median Progression free survival (PFS)
Time frame: Up to12 weeks
Duration of response (DOR)
Time frame: Up to12 weeks
The percentage of improvement
Time frame: Up to 12 weeks
Adverse Events CTCAE
Time frame: Up to 6 weeks
Cytokine Release Syndrome (CRS)
Time frame: Up to 6 weeks
Immune effector cell-associated neurotoxicity syndrome (ICANS)
Time frame: Up to 6 weeks
Overall survival
Time frame: Up to 5 years
Persistence and expansion of ATLCAR.CD30
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink 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.
Matthew I Milowsky principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATLCAR.CD30 Cells, Cyclophosphamid and Fludarabine in people with Germ Cell Tumor and Nonseminomatous Germ Cell Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Overall response rate (ORR)- Response Evaluation Criteria In Solid Tumors Criteria (RECIST) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.