OncoMatch/Clinical Trials/NCT06316427
Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies
Is NCT06316427 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Autologous CD7 CAR T-cell and Prior-HSCT donor-derived CD7 CAR T-cell for t-cell acute lymphoblastic leukemia.
Treatment: Autologous CD7 CAR T-cell · Prior-HSCT donor-derived CD7 CAR T-cell · New donor-derived CD7 CAR T-cell — This is a multi-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD7 overexpression (>80% of tumour cells expressing CD7 with MFI similar to normal T cells (fully positive); >80% with MFI at least 1 log lower than normal T cells (dim); 20-80% (partial); IHC >30%)
Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: >80% of tumour cells expressing CD7 with a mean fluorescence intensity [MFI] of CD7 similar to that of normal T cells are considered to have fully positive expression; >80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression [dim]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: >30%)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value [excluded]
Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value [excluded]
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