Actively Recruiting

Phase 1
Phase 2
Age: 2Years - 75Years
All Genders
NCT04781634

a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-02-25

40

Participants Needed

1

Research Sites

329 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL

CONDITIONS

Official Title

a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

Who Can Participate

Age: 2Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent
  • Diagnosed with relapsed or refractory B-ALL meeting at least one of: failed standard chemotherapy, relapse after remission with high-risk/refractory status, or relapse after hematopoietic stem cell transplantation
  • For Ph+ ALL patients: received standard induction chemotherapy and either did not achieve remission after TKI treatment or relapsed after remission (excluding TKI-resistant patients)
  • Evidence of CD19 or CD22 cell membrane expression
  • All genders aged 2 to 75 years
  • Expected survival time greater than 3 months
  • Karnofsky Performance Status (KPS) over 60
  • No serious mental disorders
  • Left ventricular ejection fraction 50% or higher
  • Adequate liver function: ALT/AST no more than 3 times upper limit of normal (ULN), bilirubin no more than 2 times ULN
  • Adequate kidney function: creatinine clearance no more than 2 times ULN
  • Adequate lung function: oxygen saturation 92% or higher indoors
  • Eligible for single or venous blood collection with no contraindications
  • Ability and willingness to follow study visits and protocol requirements
Not Eligible

You will not qualify if you...

  • History of other malignancies
  • Presence of uncontrolled active infection
  • Disorders requiring glucocorticoid treatment
  • Active or chronic graft-versus-host disease (GVHD)
  • Treatment with T cell inhibitors
  • Pregnant or breastfeeding women
  • Any condition deemed unsuitable by investigators, such as HIV, HCV infection, or intravenous drug addiction, that may affect study participation or data analysis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

Actively Recruiting

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Research Team

Z

Zhi Yang, PhD

CONTACT

S

Sanbin Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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