CD7-Specific CAR T-Cell Therapy for T-cell Malignancies
This study is testing a new cell therapy called CD7.CAR/28zeta T Cells for people with T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LL), or T-non-Hodgkin Lymphoma (a type of lymph gland cancer). These T cells are specially designed in the lab to find and kill cancer cells. Researchers are looking to see what dose of CD7.CAR/28zeta T Cells is safe and how well it works. The study aims to enroll 27 participants between the ages of 0 and 75. The main goal is to find out the highest dose that can be given without causing serious side effects within the first 4 weeks. The study status is currently unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 27 participants and will test four different dose levels of the CD7.CAR/28zeta T Cells.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for a total of 15 years to monitor for any long-term side effects.
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NCT07220993
Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car T Cells
Recruiting
PHASE1Up to 75InterventionalTreatmentBaylor College of MedicineInvestigator-initiated
~27 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:CD7.CAR/28zeta T Cells
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity rate
Measured over 4 weeks
Conditions
Where it's being run
2 sites across 1 statesTexas2
Study leadership
- Rayne Rouce, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
- LaQuisa Hill, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
Who to contact
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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 a suitable donor identified by a FACT accredited transplant center
willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates.
CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory).
Age ≤75 years old.
Hgb ≥ 7.0 g/dL (can be transfused)
Life expectancy greater than 12 weeks
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.
Informed consent explained to, understood by and signed by patient/LAR. Patient/LAR given copy of informed consent.
suitable for allogeneic hematopoietic stem cell transplant (HSCT)
with a suitable donor identified by a FACT accredited transplant center
willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates.
CD7-positive tumor (≥20% CD7+ blasts or tumor cells by flow cytometry or immunohistochemistry (tissue) assessed in a CLIA certified Flow Cytometry/Pathology laboratory.
Age ≤75 years old.
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 treatments (i.e. chemotherapy) at least one week before entering this study.
≥ 60 days post-allogeneic HSCT at time of treatment.
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.
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.
Informed consent explained to, understood by, and signed by patient/guardian. Patient/guardian given copy of informed consent.
Exclusion
Active infection requiring antibiotics
Active infection with HIV
History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.
Currently receiving any investigational agents or having received any tumor vaccines within the previous 4 weeks.
History of hypersensitivity reactions to murine protein-containing products.
Pregnant or lactating.
Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).
Clinically significant infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6.
Evidence of acute GVHD \> Grade II or active chronic GVHD \> mild global severity score.
Currently taking corticosteroids for therapy at a dose of \>0.5mg/kg prednisone equivalent.
Patients who have received immunosuppressive treatment (IST) for GVHD within 28 days of infusion.
Patients who have received donor lymphocyte infusion (DLI) within 28 days of infusion
Any of the following cardiac criteria: Uncontrolled atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion; LVSF\<30% or LVEF\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA III or IV. \*Study requires cardiac echocardiography confirmation of absence of these conditions within 12 months of treatment.
CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3 (unless negative by the Steinherz/Bleyer algorithm); Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage within the past 12 months, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
What this trial measures
- Dose limiting toxicity rate4 weeks
Defined as the proportion of subjects in each group with DLT evaluated as per the CTCAE 5.0 with the exception of Cytokine Release Syndrome (CRS) and neurological toxicities that are related to T cell infusions.