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uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

NCT07109518 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-03

No results posted yet for this study

Summary

The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.

Conditions

  • Acute Myeloid Leukemia (AML)
  • T Lymphoblastic Leukemia/Lymphoma

Interventions

BIOLOGICAL

uCD7 CART

Subjects screened to meet the requirements for uCD7 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine (Flu) and cyclophosphamide (CTX) based preconditioning should be performed within 1 week prior to uCD7 CART infusion: Flu 30mg/m2 ×3 days; CTX 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and etoposide. Infusion of uCD7 CART must be performed 24 hours after completion of chemotherapy preconditioning. uCD7 CART can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Jianxiang Wang · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-28
Primary Completion
2028-06-28
Completion
2030-06-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109518 on ClinicalTrials.gov