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NOT YET RECRUITING
NCT07117305
PHASE1/PHASE2

CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation

Sponsor: Zhengzhou University

View on ClinicalTrials.gov

Summary

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.

Official title: A Clinical Investigation Into the Safety and Efficacy of CD7 Chimeric Antigen Receptor T-cell (CAR-T) Therapy in Combination With Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed/Refractory T-cell Lymphoma

Key Details

Gender

All

Age Range

14 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2025-09-01

Completion Date

2027-12-01

Last Updated

2025-08-12

Healthy Volunteers

No

Interventions

DRUG

CD7 CAR-T combined with autologous hematopoietic stem cell transplantation

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.

Locations (1)

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, China