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CAR T-Cell Therapy for T-Cell Cancers

This study is testing a new way to fight T-cell cancers like T-cell Acute Lymphoblastic Leukemia and T-non-Hodgkin Lymphoma. It uses your own (Autologous) or a donor's (Allogeneic) special immune cells called T-cells. These T-cells are modified in the lab to recognize and attack cancer cells that have a specific marker called CD5. The modified cells are called CD5.CAR/28zeta CAR T cells. Before receiving these cells, you will get chemotherapy (cyclophosphamide and fludarabine) to prepare your body. Researchers will look for side effects and how well the treatment works. The study aims to find the safest dose of these modified T-cells. This study is currently not recruiting new participants.

Study design
This interventional study plans to enroll 54 participants. It is testing three different dose levels of CD5.CAR/28zeta CAR T cells.
What's involved
You would provide blood for the T-cell modification. You would receive chemotherapy for three days, followed by the CD5.CAR/28zeta CAR T cells.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 15 years to monitor for any long-term side effects of the gene transfer.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03081910

Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen

Recruiting
PHASE1Up to 75InterventionalTreatment
Baylor College of Medicine
~54 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Autologous CD5.CAR/28zeta CAR T cellsAllogeneic CD5.CAR/28zeta CAR T cells

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (DLT) rate
Measured over 6 weeks post-infusion

Conditions

T-cell Acute Lymphoblastic Lymphoma
T-non-Hodgkin Lymphoma
T-cell Acute Lymphoblastic Leukemia

Explore related trials

Adult T Lymphoblastic LymphomaNon-Hodgkin LymphomaPre T-ALLCD5 Gene

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Rayne Rouce, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Rayne Rouce, MD
[email protected]
832-824-4716
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution
Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.
For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated. 2. CD5-positive tumor (result can be pending at this time). \> 50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory. 3. Age ≤75 years old. NOTE: The first six (6) patients treated on the study should be adults (\>18 yrs of age). 4. Life expectancy of greater than 12 weeks. 5. Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation 6. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. 7. Hgb greather than or equal to 7.0 g/dL (can be transfused) 8. If pheresis required to collect blood:
Creatinine \<1.5 × upper limit normal
AST \<1.5 × upper limit normal
PT and APTT \<1.5 × upper limit normal
Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution
Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.
For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated. 2. CD5-positive tumor. \>50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory. 3. Age \<75 years old. NOTE: The first six (6) patients treated on the study should be adults (\>18 yrs of age). 4. Bilirubin less than 3 times the upper limit of normal. 5. AST less than 5 times the upper limit of normal. 6. Estimated GFR \> 60 mL/min. 7. Pulse oximetry of \> 90% on room air. 8. Karnofsky or Lansky score of ≥ 60%. 9. Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study. 10. ≥ 60 days post-allogeneic HSCT at time of treatment. 11. Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation. 12. 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. 13. Informed consent explained to, understood by, and signed by patient/guardian. Patient/guardian given copy of informed consent.

What this trial measures

  • Dose limiting toxicity (DLT) rate6 weeks post-infusion

    Defined as the proportion of subjects in each group with DLT evaluated as per the CTCAE 4.0 with the exception of Cytokine Release Syndrome (CRS) and neurological toxicities that are related to T cell infusions.