Non-Hodgkin LymphomaPhase 1SAGANNCT01853631
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
A Phase 1 study testing Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells and Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphocytic Leukemia
- What is being tested?
- Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells and Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Feb 2036
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PROCUREMENT
- Referred patients (or respective donors) will initially be consented for procurement of blood for generation of the transduced ATL. Eligibility criteria at this stage include:
- Diagnosis of recurrent B-cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
- CD19-positive tumor (result can be pending at this time).
- Age <= 75 years. The first 3 patients treated on the study should be adults (>= 18 years).
- Hgb greater than or equal to 7.0 (can be a transfused value)
Show all 25Show fewer
- If pheresis required to collect blood:
- Creatinine < 1.5 x upper limit normal
- AST <1.5 × upper limit normal
- PT and APTT <1.5 × upper limit normal
- Informed consent explained to, understood by and signed by patient/guardian (and donor, where applicable). Patient/guardian given copy of informed consent.
- TREATMENT
- Diagnosis of recurrent B-cell lymphoma leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
- CD19-positive tumor.
- Age <= 75 years. The first 3 patients treated on the study should be adults (>= 18 years).
- Bilirubin less than 3 times the upper limit of normal.
- AST less than 5 times the upper limit of normal.
- Estimated GFR > 50 mL/min
- Pulse oximetry of > 90% on room air
- Karnofsky or Lansky score of > 60%.
- Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study. PD1/PDL1 inhibitors will be allowed if medically indicated.
- Available autologous or syngeneic activated peripheral blood T cell products (CD28ζ and CD28/CD137ζ) with more than or equal to 15% expression of CD19.CAR determined by flow cytometry.
- Life expectancy of greater than 12 weeks.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
Who cannot join
- PROCUREMENT
- Active infection requiring antibiotics.
- No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.
- TREATMENT
- Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks. (Note treatment with PD1/PDL1 inhibitors is allowed.)
- History of hypersensitivity reactions to murine protein-containing products.
Show all 9Show fewer
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
- Active infection with HIV or HTLV.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Martha Arredondo contact
United States2 sites, 2 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Carlos A. Ramos, MD, CARamos@houstonmethodist.org
Martha Arredondo, mearredo@texaschildrens.org
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Helen E. Heslop, MD, hheslop@bcm.edu
Martha Arredondo, mearredo@texaschildrens.org
About this study
Official title: Phase I Study of Activated T-Cells Expressing Second or Third Generation CD19-Specific Chimeric Antigen Receptors for Advanced B-Cell Non-Hodgkin's Lymphoma, Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia (SAGAN)
Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment.
The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients.
Read more
T cells can kill tumor cells but normally there are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.
The antibody used in this study is called anti-CD19. It first came from mice that have developed immunity to human lymphoma. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, anti-CD19 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor.
In the laboratory, the investigators found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells last longer in the body but not long enough for them to be able to kill the lymphoma cells. The investigators believe that if they add an extra stimulating protein, called CD137, the cells will have a better chance of killing the lymphoma cells.
The investigators are going to see if this is true by putting the CD19 chimeric receptor with CD28 alone into half of the cells and the CD19 chimeric receptor with CD28 and CD137 into the other half of the cells. These CD19 chimeric receptor T cells with CD28 and with or without CD137 are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to see how long the T cell with each sort of chimeric receptor lasts, to learn what the side effects are and to see whether this therapy might help people with lymphoma or leukemia.
Read the detailed description
Patients will give the investigators blood to make CD19 CD28 (with and without CD137) chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, investigators will take blood (or blood from a donor) and stimulate it with growth factors to make the T cells grow. To get the CD19 antibody and CD28 (with or without CD137) to attach to the surface of the T cell, they will insert the antibody gene into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps to find the T cells in the blood after injecting them; in order to tell them apart investigators have made two viruses that are slightly different because one has CD137. These two viruses can be told apart by a special laboratory test. Because the patient will receive cells with a new gene in them, the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer. If the patient cannot visit the clinic, he or she will be contacted by the research coordinator or physician.
When subjects enroll on this study, they will be assigned a dose of CD19 chimeric receptor-T cells. Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation.
Because of that, if the subject's level of circulating T cells is relatively high, s/he may receive one treatment of cyclophosphamide (Cytoxan) and fludarabine if the doctor thinks this is appropriate. This drug will decrease the numbers of the subject's own T cells before infusion of the CD19 chimeric receptor T cells. If subject is already receiving chemotherapy, this may not be needed. The investigators would prefer subjects do not receive other chemotherapy until 6 weeks after cell infusion but they can do so if their doctor thinks it is medically necessary.
Patients will be given an injection of cells into the vein through an IV at the assigned dose. The injection will take about 20 minutes. The investigators will follow them in the clinic after the injection for up to 3 hours.
If after a 6 week evaluation period after the infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), s/he may be able to receive up to five additional doses of the T cells if s/he wishes. The first repeat infusion can only take place at least 6 weeks after the first infusion. Any additional infusions after that would be at least 4 weeks apart. All additional infusions will be at the same dose level received the first time or a lower dose. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
- Being tested
- Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells, Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells
- Keywords
- chronic Lymphocytic Leukemia, refractory, recurrent, aggressive B-cell Lymphoma, CD19, Non-Hodgkin Lymphoma, CD28, CD137, 4-1BB, acute lymphocytic leukemia
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cellsGenetic
Three dose levels will be evaluated.
Group 1: CD19.CAR/28137ζ at 1×10^6 cells/m^2 and CD19.CAR/28ζ at 1×10^6 cells/m^2
Group 2: CD19.CAR/28137ζ at 5×10^6 cells/m^2 and CD19.CAR/28ζ at 5×10^6 cells/m^2
Group 3: CD19.CAR/28137ζ at 2×10^7 cells/m^2 and CD19.CAR/28ζ at 2×10^7 cells/m^2
Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cellsGenetic
The primary goal of the expanded cohort is to further study the safety profiles of CAR-T cells in each of the disease settings, both with or without lymphodepleting chemotherapy given before CAR-T cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: CD19 CAR T Cells for B-cell ALL | Experimental | Each patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. Receives: Genetic: Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells |
| Dose Expansion: CD19 CAR T Cells for B-cell ALL | Experimental | Each patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. Receives: Genetic: Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells |
| Dose Escalation: CD19 CAR T Cells for B-cell NHL/CLL | Experimental | Each patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. Receives: Genetic: Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells |
| Dose Expansion: CD19 CAR T Cells for B-cell NHL/CLL | Experimental | Each patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. Receives: Genetic: Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity (DLT)
Toxicity will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 4. DLT will be defined as any of the following that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are predisposed), or (3) due to underlying malignancy, and that may, after consultation with the FDA when indicated, be considered possibly, probably, or definitely related to the study cellular products: (1) Non-hematologic DLT is any grade 3 or grade 4 non-hematologic toxicity, including allergic reactions to T cell infusions; (2) Hematologic DLT is defined as any grade 4 hematologic toxicity. Patients with evidence of bone marrow disease (metastases or diffuse infiltration) are not evaluable for hematologic dose limiting toxicity.
Measured: 6 weeks
Secondary outcomes (5)
Survival of CD19.CAR-ATLs
Survival will be measured by a real time Q-PCR assay to detect CD19.CAR-ATLs in peripheral blood from subjects. Plots will be generated to depict patterns of survival. Also, longitudinal modeling techniques will be used.
Measured: 15 years
Frequency of the two distinct T cell products post infusion
To compare the changes in frequency of two different T-cell products in the same patient, two different Q-PCR assays will be used, which distinguish each CAR by the presence or absence of the CD137 co-stimulatory endodomain gene.
Measured: 15 years
Number of patients with tumor response
Tumor responses will be assessed by the International Working Group Revised Response Criteria for Malignant Lymphoma or the National Cancer Institute CLL Working Group Recommendations, as applicable.
Measured: 15 years
Percentage of circulating modified T cells after additional doses
Changes in the percentage of circulating modified T cells after additional doses will be measured by each respective real time Q-PCR assay to detect CD19.CAR-ATLs in peripheral blood from subjects. Plots will be generated to depict patterns of survival. Also, longitudinal modeling techniques will be used.
Measured: 15 years
Function of CD19.CAR-ATLs
To study the function of CD19.CAR-ATLs, the following assays will be performed on PBMCs isolated from subjects: (1) ELISPOT for interferon-gamma release using CD19-positive cells and CD19-negative target cells; (2) Other functional assays, such as in vitro reactivation of PBMCs, in patients on whom the appropriate reagents are available; and (3) Immunophenotyping.
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2026 (estimated)
- Study completionFeb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Carlos A Ramos, MD, Principal investigator, The Methodist Hospital Research InstituteHelen Heslop, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853631
- Sponsor's protocol ID
- H-31970 SAGAN
- Other IDs
- SAGAN
- Acronym
- SAGAN
- Status last verified
- Sep 2026
- First submitted
- 1 May 2013
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo M, Zhang H, Zhu L, Xu Q, Gao Q. CAR-T Cell Therapy: Challenges and Optimization. Crit Rev Immunol. 2021;41(1):77-87. doi: 10.1615/CritRevImmunol.2021037253.
PubMed 33822526
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Activated T-Cells Expressing Second or Third Generation CD19-Specific Chimeric Antigen Receptors for Advanced B-Cell Non-Hodgkin's Lymphoma, Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia (SAGAN)
- ClinicalTrials.gov ID
- NCT01853631
- Acronym / sponsor ID
- SAGAN / H-31970 SAGAN
- Keywords
- chronic Lymphocytic Leukemia, refractory, recurrent, aggressive B-cell Lymphoma, CD19, Non-Hodgkin Lymphoma, CD28, CD137
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Feb 2014
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2036 (estimated)
- First posted
- 15 May 2013 (estimated)
- 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.
Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment.
The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients.
T cells can kill tumor cells but normally there are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.
The antibody used in this study is called anti-CD19. It first came from mice that have developed immunity to human lymphoma. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, anti-CD19 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor.
In the laboratory, the investigators found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells last longer in the body but not long enough for them to be able to kill the lymphoma cells. The investigators believe that if they add an extra stimulating protein, called CD137, the cells will have a better chance of killing the lymphoma cells.
The investigators are going to see if this is true by putting the CD19 chimeric receptor with CD28 alone into half of the cells and the CD19 chimeric receptor with CD28 and CD137 into the other half of the cells. These CD19 chimeric receptor T cells with CD28 and with or without CD137 are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to see how long the T cell with each sort of chimeric receptor lasts, to learn what the side effects are and to see whether this therapy might help people with lymphoma or leukemia.
Detailed description
Patients will give the investigators blood to make CD19 CD28 (with and without CD137) chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, investigators will take blood (or blood from a donor) and stimulate it with growth factors to make the T cells grow. To get the CD19 antibody and CD28 (with or without CD137) to attach to the surface of the T cell, they will insert the antibody gene into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps to find the T cells in the blood after injecting them; in order to tell them apart investigators have made two viruses that are slightly different because one has CD137. These two viruses can be told apart by a special laboratory test. Because the patient will receive cells with a new gene in them, the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer. If the patient cannot visit the clinic, he or she will be contacted by the research coordinator or physician.
When subjects enroll on this study, they will be assigned a dose of CD19 chimeric receptor-T cells. Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation.
Because of that, if the subject's level of circulating T cells is relatively high, s/he may receive one treatment of cyclophosphamide (Cytoxan) and fludarabine if the doctor thinks this is appropriate. This drug will decrease the numbers of the subject's own T cells before infusion of the CD19 chimeric receptor T cells. If subject is already receiving chemotherapy, this may not be needed. The investigators would prefer subjects do not receive other chemotherapy until 6 weeks after cell infusion but they can do so if their doctor thinks it is medically necessary.
Patients will be given an injection of cells into the vein through an IV at the assigned dose. The injection will take about 20 minutes. The investigators will follow them in the clinic after the injection for up to 3 hours.
If after a 6 week evaluation period after the infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), s/he may be able to receive up to five additional doses of the T cells if s/he wishes. The first repeat infusion can only take place at least 6 weeks after the first infusion. Any additional infusions after that would be at least 4 weeks apart. All additional infusions will be at the same dose level received the first time or a lower dose. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: CD19 CAR T Cells for B-cell ALL | Experimental | Genetic: Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cellsEach patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. |
| Dose Expansion: CD19 CAR T Cells for B-cell ALL | Experimental | Genetic: Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cellsEach patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. |
| Dose Escalation: CD19 CAR T Cells for B-cell NHL/CLL | Experimental | Genetic: Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cellsEach patient will receive a dose of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. |
| Dose Expansion: CD19 CAR T Cells for B-cell NHL/CLL | Experimental | Genetic: Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cellsEach patient will receive the maximum tolerated dose (MTD) of CD19 CAR T Cells administered as an infusion. Each infusion will consist of CD19.CAR/28 T cells and CD19.CAR/28137 T cells. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- PROCUREMENT
- Referred patients (or respective donors) will initially be consented for procurement of blood for generation of the transduced ATL. Eligibility criteria at this stage include:
- Diagnosis of recurrent B-cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
- CD19-positive tumor (result can be pending at this time).
- Age <= 75 years. The first 3 patients treated on the study should be adults (>= 18 years).
Key exclusion criteria (9 listed)
- PROCUREMENT
- Active infection requiring antibiotics.
- No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.
- TREATMENT
- Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks. (Note treatment with PD1/PDL1 inhibitors is allowed.)
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 |
|---|---|---|
| Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cellsThree dose levels will be evaluated. Group 1: CD19.CAR/28137ζ at 1×10^6 cells/m^2 and CD19.CAR/28ζ at 1×10^6 cells/m^2 Group 2: CD19.CAR/28137ζ at 5×10^6 cells/m^2 and CD19.CAR/28ζ at 5×10^6 cells/m^2 Group 3: CD19.CAR/28137ζ at 2×10^7 cells/m^2 and CD19.CAR/28ζ at 2×10^7 cells/m^2 | Genetic | Dose Escalation: CD19 CAR T Cells for B-cell ALL, Dose Escalation: CD19 CAR T Cells for B-cell NHL/CLL |
| Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cellsThe primary goal of the expanded cohort is to further study the safety profiles of CAR-T cells in each of the disease settings, both with or without lymphodepleting chemotherapy given before CAR-T cell infusion. | Genetic | Dose Expansion: CD19 CAR T Cells for B-cell ALL, Dose Expansion: CD19 CAR T Cells for B-cell NHL/CLL |
Primary outcome
Number of patients with dose limiting toxicity (DLT)
Time frame: 6 weeks
Toxicity will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 4. DLT will be defined as any of the following that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are predisposed), or (3) due to underlying malignancy, and that may, after consultation with the FDA when indicated, be considered possibly, probably, or definitely related to the study cellular products: (1) Non-hematologic DLT is any grade 3 or grade 4 non-hematologic toxicity, including allergic reactions to T cell infusions; (2) Hematologic DLT is defined as any grade 4 hematologic toxicity. Patients with evidence of bone marrow disease (metastases or diffuse infiltration) are not evaluable for hematologic dose limiting toxicity.
5 secondary outcomes
Survival of CD19.CAR-ATLs
Time frame: 15 years
Frequency of the two distinct T cell products post infusion
Time frame: 15 years
Number of patients with tumor response
Time frame: 15 years
Percentage of circulating modified T cells after additional doses
Time frame: 15 years
Function of CD19.CAR-ATLs
Time frame: up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 33822526Luo M, Zhang H, Zhu L, Xu Q, Gao Q. CAR-T Cell Therapy: Challenges and Optimization. Crit Rev Immunol. 2021;41(1):77-87. doi: 10.1615/CritRevImmunol.2021037253.
- Individual participant dataSharing planned: No
Related trials for Non-Hodgkin Lymphoma
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Tissue Collection for Studies of Lymph Cancer
Hodgkin Disease, Lymphoma, Non-Hodgkin
Active, not recruitingPhase 1
Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma
Advanced Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
Active, not recruitingPhase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type
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.
Martha Arredondo contact
Carlos A Ramos, MD principal investigator
The Methodist Hospital Research Institute
Helen Heslop, MD principal investigator
Baylor College of Medicine
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 Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells and Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Baylor College of Medicine 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 25 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos A Ramos, MD ((713) 441-1450, CARamos@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicity (DLT) (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 NCT01853631, 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 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.