RecruitingPhase 1Phase 2NCT04016129

CAR-T Immunotherapy Targeting CD19- ALL

CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

100 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria6

  • Age older than 6 months.
  • Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
  • Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
  • The KPS score over 80 points, and survival time is more than 1 month.
  • Greater than Hgb 80 g/L.
  • No contraindications to blood cell collection.

Exclusion Criteria6

  • Complications with other active diseases, and difficult to assess patient response.
  • Bacteria, fungus, or virus infection, and unable to control.
  • Living with HIV.
  • Active HBV and HCV infection.
  • Pregnant and nursing mothers.
  • Under systemic steroid use within a week of the treatment.

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Interventions

BIOLOGICAL4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR

4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies


Locations(3)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Zhongxi Children Hospital

Shijiazhuang, Hebei, China

View Full Details on ClinicalTrials.gov

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NCT04016129


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