Multi-CAR-T Cells Targeting B Cell Lymphomas

  • STATUS
    Recruiting
  • participants needed
    11
  • sponsor
    Shenzhen Geno-Immune Medical Institute
Updated on 19 February 2024

Summary

This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Description

Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, post CD19-CART relapses occur at high rate due to the CD19 antigen loss or the exhaustion of CART cells. Furthermore, the success of treating relapsed/refractory B cell lymphoma (BCL) such as primary mediastinal B-cell lymphoma (PMBCL) and CNS-involved BCL has been limited. To overcome tumor escape and prolong in vivo CART efficacy, we have developed a novel multiple CAR-T therapy regimen including booster and consolidation CART applications to to target highly-refractory cancer. Selected patients will be enrolled after target antigen confirmation including CD19, CD20, CD22, CD70, CD13, CD79b, GD2 and PSMA through immunostaining of their tumor specimens. The aim is to evaluate safety and long term efficacy of the multiple CART therapy strategy in the BCL patients.

Details
Condition Lymphoma, B-Cell Lymphoma
Age 1-75 years
Treatment 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2
Clinical Study IdentifierNCT04429438
SponsorShenzhen Geno-Immune Medical Institute
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Age older than 6 months
Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules
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

Accompanied with other active diseases, and difficult to assess response after treatment
Bacterial, fungal, or viral infection, unable to control
Living with HIV
Active HBV and HCV infection
Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment
Prior failed CAR-T treatment
Clear my responses

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