Actively Recruiting

Phase 1
Phase 2
Age: 6Months - 75Years
All Genders
NCT04016129

CAR-T Immunotherapy Targeting CD19- ALL

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-04-23

100

Participants Needed

3

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

CONDITIONS

Official Title

CAR-T Immunotherapy Targeting CD19- ALL

Who Can Participate

Age: 6Months - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 6 months
  • Diagnosis of native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy
  • Malignant B cells expressing one or more of the following surface markers: CD22, CD123, CD38, CD10, CD20, or TSLPR
  • Karnofsky Performance Status (KPS) score over 80 points with expected survival time more than 1 month
  • Hemoglobin level greater than 80 g/L
  • No contraindications to blood cell collection
Not Eligible

You will not qualify if you...

  • Presence of other active diseases that complicate assessment of patient response
  • Uncontrolled bacterial, fungal, or viral infections
  • Living with HIV infection
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Pregnant or nursing mothers
  • Systemic steroid use within one week before treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510282

Actively Recruiting

2

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China, 518000

Actively Recruiting

3

Zhongxi Children Hospital

Shijiazhuang, Hebei, China, 050006

Actively Recruiting

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Research Team

L

Lung-Ji Chang, PhD

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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CAR-T Immunotherapy Targeting CD19- ALL | DecenTrialz