4SCAR-T Therapy Post CD19-targeted Immunotherapy

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Shenzhen Geno-Immune Medical Institute
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Updated on 19 February 2024
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Summary

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation 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.

Description

Anti-CD19 immunotherapy based on antibody conjugated drugs or CD19-CAR-T cells has demonstrated unprecedented positive response in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many patients still relapse and up to 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.

Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, the 4th generation CAR gene-modified T cells targeting CD22, CD10, CD20, CD38, or CD123 have been considered in post anti-CD19 treatment. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-escaped B cell malignancies.

Details
Condition CD19 Negative B-cell Malignancies
Age 1years - 75years
Treatment Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20
Clinical Study IdentifierNCT04430530
SponsorShenzhen Geno-Immune Medical Institute
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age older than 6 months
B cell malignancies relapsed after anti-CD19 immunotherapy
Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20
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 Criteria

Complications with other active diseases, and difficult to assess patient response
Bacterial, fungal, or viral infection 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
Judged difficult to cooporate for continued evaluation
Clear my responses
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