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Cell Therapy for High-Risk T-Cell Malignancies

This study is testing a cell therapy called CD7.CAR/28zeta CAR T cells for people with high-risk T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL). These are types of blood cancer. The treatment involves taking your own T cells (special infection-fighting blood cells), modifying them in the lab to better target cancer cells, and then giving them back to you. Researchers want to see if this treatment is safe and what dose works best. They will measure how many patients experience serious side effects within four weeks. The study aims to enroll 45 participants between the ages of None and 75 years old.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 45 participants and will test three different dose levels of the CD7.CAR/28zeta CAR T cells.
What's involved
You will first provide blood for the creation of the T cells. After receiving the cells, you will be followed for a total of 15 years to monitor for long-term side effects.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a total of 15 years to monitor for long-term side effects of 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.

NCT03690011

Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells

Active, Not Recruiting
PHASE1Up to 75InterventionalTreatment
Baylor College of Medicine
~45 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:CD7.CAR/28zeta CAR T cells

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with dose limiting toxicity
Measured over 4 weeks

Conditions

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

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NCT03690011

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Houston Methodist Hospital

    Houston, Texasno site contact published

  • Texas Children's Hospital

    Houston, Texasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rayne Rouce, MD · PRINCIPAL_INVESTIGATOR · Pediatrics, Baylor College of Medicine
  • LaQuisa Hill, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.
Cr \< 1.5 upper limit normal
AST \< 5 × upper limit normal
PT and APTT \<1.5 × upper limit normal
For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.

What this trial measures

  • Number of patients with dose limiting toxicity4 weeks

    To evaluate the safety of escalating doses of autologous peripheral blood T lymphocytes (ATLs) genetically modified to express chimeric antigen receptors (CAR) targeting the CD7 molecule (CD7.CAR) in combination with lymphodepletion in patients with relapsed/refractory T-cell malignancies.