Actively Recruiting
Novel Unedited Allo Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR T Cells
Led by Baylor College of Medicine · Updated on 2026-05-18
27
Participants Needed
2
Research Sites
782 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on patients with T-cell leukemia or lymphoma, which are types of blood and lymph gland cancers. It explores a novel treatment approach combining antibodies and T cells to fight the disease. The study specifically investigates CD7 chimeric receptor T cells with an added protein called CD28, aiming to improve the ability of these cells to target and kill cancer cells. These investigational cells are not yet approved by the Food and Drug Administration. The treatment involves using T cells collected from the patient's previous bone marrow transplant donor. These T cells are genetically modified in the lab using a retrovirus to attach the CD7 antibody and CD28 protein, then grown and frozen for infusion. Patients receive chemotherapy with cyclophosphamide and fludarabine for three days before the T cell infusion to reduce their own T cells and make room for the new cells. The modified T cells are then given through an intravenous injection, with four dose levels being evaluated. Participants undergo various medical tests before, during, and after treatment, including physical exams, blood tests, tumor scans, and heart ultrasounds. Blood samples will be collected regularly for up to 15 years to study how long the modified T cells last and their effects. After infusion, patients remain near the clinic for at least four weeks for monitoring, with possible hospitalization if side effects occur. The primary outcome measured is the rate of dose-limiting toxicity within four weeks, along with overall response rate.
CONDITIONS
Brief Title
Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma, or T-cell non-Hodgkin lymphoma including specific subtypes
- Relapsed after allogeneic related donor hematopoietic stem cell transplant (HSCT)
- Suitable for allogeneic HSCT with a suitable donor identified by a FACT accredited center
- Willing to proceed to transplant if complete remission is achieved
- CD7-positive tumor with 20% or more CD7-positive blasts or tumor cells
- Age 75 years or younger
- Hemoglobin 7.0 g/dL or higher (can be transfused)
- Life expectancy greater than 12 weeks
- Available partially-HLA matched allogeneic EBV-specific T cell line for treatment if needed
- Informed consent signed and understood by patient or legal representative
- Adequate organ function including bilirubin, AST, and kidney function
- Pulse oximetry greater than 90% on room air
- Karnofsky or Lansky score 60% or higher
- Recovery from prior treatment toxic effects at least one week before study
- At least 60 days post-allogeneic HSCT at time of treatment
- Use of effective birth control methods during and for 6 months after the study for sexually active patients
You will not qualify if you...
- Active infection requiring antibiotics
- Active infection with HIV
- History of other cancer unless treated with curative intent at least 2 years before trial entry
- Receiving any investigational agents or tumor vaccines within 4 weeks
- Hypersensitivity to murine protein-containing products
- Pregnant or lactating
- Tumor location posing risk of airway obstruction
- Clinically significant infection or uncontrolled viral reactivation
- Acute graft-versus-host disease (GVHD) above Grade II or active chronic GVHD above mild severity
- Taking corticosteroids above 0.5 mg/kg prednisone equivalent
- Immunosuppressive treatment for GVHD within 28 days
- Donor lymphocyte infusion within 28 days
- Certain cardiac conditions including recent myocardial infarction or poor heart function
- Central nervous system abnormalities such as uncontrolled seizures or cerebrovascular events within 12 months or CNS-3 disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week including chemotherapy and infusion
Participants receive chemotherapy with cyclophosphamide and fludarabine over 3 days to prepare their body, followed by an infusion of CD7 chimeric receptor-T cells. Before the infusion, participants receive medications to reduce side effects. The cell infusion takes about 1 to 10 minutes, and participants are monitored in the clinic for up to 3 hours after.
3 daily chemotherapy visits and 1 infusion visit (all in-person)
Duration - Up to 15 years
Participants are monitored closely after infusion with physical exams, blood tests, and tumor assessments to check response and safety. Follow-up includes frequent visits and blood draws during the first 8 weeks and then regularly for up to 15 years to observe long-term effects of the gene therapy.
Multiple visits: weekly for first 4 weeks, then at 6 and 8 weeks, 3, 6, 9, 12 months, every 6 months for 4 years, then yearly thereafter
Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Rayne Rouce
L
LaQuisa Hill, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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