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QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

NCT06056752 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-24

No results posted yet for this study

Summary

This is a single-arm, single-center, interventional, dose-escalation clinical study designed to evaluate the safety and tolerability of QH103 Cell Injection in the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Conditions

Interventions

BIOLOGICAL

QH103 Cell Injection

dose escalation (3+3) : dose 1 (3×10\^8CAR+cells) ,dose 2 (1 × 10\^9 CAR+cells）,dose 3 (3 × 10\^9CAR+cells)

DRUG

Fludarabine

Intravenous fludarabine on days-5\~-2,the infusion dose is adjusted according to the subject's condition

DRUG

Cyclophosphamide

Intravenous cyclophosphamide on days -5\~-3, the infusion dose is adjusted according to the subject's condition

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Xiaoyu Zhu, Ph.D · Director of Hematology Department, Anhui Provincial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2025-07-03
Completion
2026-07-03

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06056752 on ClinicalTrials.gov