RecruitingPhase 1Phase 2NCT04429438

Multi-CAR-T Cells Targeting B Cell Lymphomas

Primary, Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

11 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICAL4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2

Patients who have relapsed and refractory B cell lymphoma (BCL) after conventional chemotherapy will be treated with multiple 4SCAR gene-engineered T cells


Locations(2)

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, China

The Seventh Affilliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04429438