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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from patients.
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from prior-HSCT donors.
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from new donors.
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
RECRUITINGZhaxin Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Liquan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe General Hospital of Western Theater Command PLA
Chengdu, Sichuan, China
NOT_YET_RECRUITINGDose-Limiting Toxicity (DLT) in phase I
Type and incidence of dose-limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion
Time frame: 21 days post infusion
Overall Response Rate (ORR) in phase II
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 per 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
Time frame: 3 months (± 1 week) post infusion
Overall Response Rate (ORR) in phase I
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 per 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
Time frame: 3 months (± 1 week) post infusion
Safety in phase II
The adverse events in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
Time frame: 2 years post infusion
Progression-Free Survival (PFS) in phase II
Progression-free survival (PFS) in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells.
Time frame: 2 years post infusion
Duration of Remission (DOR) in phase II
Duration of remission (DOR) in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells.
Time frame: 2 years post infusion
Overall Survival (OS) in phase II
Overall survival (OS) in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells.
Time frame: 2 years post infusion
Levels of CD7 CAR-T Cells in phase II
Levels of CD7 CAR-T cells in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Time frame: 2 years post infusion
Levels of CAR transgene in phase II
Levels of CAR transgene in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Time frame: 2 years post infusion
Levels of immune cells in phase II
Levels of immune cells in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Time frame: 2 years post infusion
Levels of cytokines in phase II
Levels of cytokines in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Time frame: 2 years post infusion
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