This is a single-arm, open-label, phase I/II clinical trial initiated by investigators to evaluate the safety, tolerability, and preliminary efficacy of CD7-targeted chimeric antigen receptor T cells (CD7 CAR-T) combined with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory CD7-positive T-cell lymphomas. Phase I adopts a standard 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy. The study includes lymphodepletion chemotherapy, ASCT, and sequential infusion of CD7 CAR-T cells. The primary objectives include: (1) Evaluate safety/tolerability of CD7 CAR-T + auto-HSCT in relapsed or refractory CD7-positive T-cell lymphomas. (2) Determine MTD and RP2D. The secondary objectives include: (1) Assess efficacy (overall response rate, complete response, duration of response, progression-free survival and overall survival. (2)Characterize PK/PD profiles. (3)Investigate anti-tumor mechanisms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Phase I adopts a standard 3+3 dose-escalation design (with exploratory doses of 1×10⁶, 2×10⁶, and 2.5×10⁶ CAR⁺ cells/kg) to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy. During screening, eligible patients will be identified and consented. In the collection phase, patients undergo two separate apheresis procedures: G-CSF-mobilized peripheral blood stem cell collection for ASCT and PBMC collection for CAR-T manufacturing. Bridging therapy and gut preparation may be performed. The pretreatment phase(recommended: BEAM therapy) starts from Day -8. Investigators may adjust the pretreatment regimen based on the patient's performance. On Day 0, autologous stem cells are infused. CD7 CAR-T cells are infused on Days 2-7 post-transplant. Follow-up visits occur on Days 10, 14, 21, 28, and Months 2, 3, 6, and 12.
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
Zhengzhou, Henan, China
The safety of CD7 CAR-T cell injection combined with autologous hematopoietic stem cell transplantation
The possible adverse reactions recorded in each item were evaluated.
Time frame: Day 28 after treatment
Efficacy indicators
The objective response rates (ORR)
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
The overall survival (OS)
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
The progression-free survival (PFS)
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Complete remission (CR)
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Event-free survival (EFS)
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
Efficacy indicators
Disease Control Rate (DOCR)
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
kinetics of CAR-T cells
Use flow cytometry or Q-PCR to monitor the kinetics of CAR-T cells.
Time frame: Day 28, Month 2, Month 3, Month 6, Month 12 after treatment
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