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Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia

NCT06585345 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-09-05

No results posted yet for this study

Summary

Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.

Conditions

  • Acute-Leukemia

Interventions

BIOLOGICAL

CD7 CAR-T cell

Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (1-100)x10\^6 CD7 CAR-T cells/kg\]

Sponsors & Collaborators

  • YakeBiotech Ltd.

    collaborator UNKNOWN

  • The General Hospital of Western Theater Command

    lead OTHER

Principal Investigators

  • Hai Yi, Ph.D · The General Hospital of Western Theater Command

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-18
Primary Completion
2027-12-31
Completion
2030-11-01

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 NCT06585345 on ClinicalTrials.gov