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Not yet recruitingPriority 3 · Moderate priorityNCT07117305

CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation

ClinicalTrials.gov

Plain-language summary

This trial is testing CD7-directed CAR-T cell therapy for patients with various types of peripheral T-cell lymphoma (PTCL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. This trial does not currently have sites in the United States. The trial is not yet open for recruitment.

Who can join (key eligibility)

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

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

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.

  • CD7 CAR-T combined with autologous hematopoietic stem cell transplantation

Treatment length
Ask the trial team for details
Visit frequency
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TrialCompass — Clinical Trial Summary

CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation

NCT07117305

Phase: Phase 1, Phase 2 | Status: Not yet recruiting | Priority: Medium

Plain-language summary

This trial is testing CD7-directed CAR-T cell therapy for patients with various types of peripheral T-cell lymphoma (PTCL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. This trial does not currently have sites in the United States. The trial is not yet open for recruitment.

Who can join

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

What's being tested

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

Trial design

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

Locations

0 US sites · 1 total

Contact

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

Sponsor: Zhengzhou University (OTHER)

Tags

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

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07117305

Prepared using TrialCompass (trialcompass.com) on August 18, 2026. For informational purposes only. Always discuss with your healthcare team.