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Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia

NCT07491263 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-24

No results posted yet for this study

Summary

This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.

Conditions

  • Relapsed/Refractory CD19-positive B-ALL

Interventions

DRUG

Cyclophosphamide

Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days).

DRUG

Fludarabine

Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days).

BIOLOGICAL

QH103 Cell Injection

Biological: CD19 CAR-γδT cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10\^8 CAR+cells) ,dose 2 (3× 10\^8 CAR+cells).

Sponsors & Collaborators

  • Fujian Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-04-30
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT07491263 on ClinicalTrials.gov