• Age 14 Years to 65 Years years
• Newly diagnosed, not yet treated
• Must be well enough for treatment (adequate performance status)

CD7 CAR-T combined with autologous hematopoietic stem cell transplantation (DRUG): 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.

Drugs / treatments: CD7 CAR-T combined with autologous hematopoietic stem cell transplantation

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Non-randomized, open-label

Enrollment target: 38 patients

Primary endpoint: The safety of CD7 CAR-T cell injection combined with autologous hematopoietic stem cell transplantation

Ages: 14 Years to 65 Years

Start date: 2025-09-01 | Est. completion: 2027-12-01

0 US sites · 1 total

Xudong Zhang, Doctor | fcczhangxd@zzu.edu.cn | 86-0371-66279567

Sponsor: Zhengzhou University (OTHER)

All T-cell lymphomas · Newly diagnosed · Relapsed/Refractory

https://clinicaltrials.gov/study/NCT07117305