Multi-CAR-T Cells Targeting B Cell Lymphomas

NCT04429438 · tracked via the Priya Life Science China tracker

Sponsor

Shenzhen Geno-Immune Medical Institute

Phase

Phase 1/2

Started

2027-06-01

Last updated

2026-08-26

Condition(s) studied

B Cell Lymphoma (BCL)

Investigational drug(s) / intervention(s)

4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2

4SCAR19 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

Study 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

Sex

ALL

Min age

6 Months

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age older than 6 months. 2. Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules. 3. The KPS score over 80 points, and survival time is more than 1 month. 4. Greater than Hgb 80 g/L. 5. No contraindications to blood cell collection. Exclusion Criteria: 1. Accompanied with other active diseases, and difficult to assess response after treatment. 2. Bacterial, fungal, or viral infection, unable to control. 3. Living with HIV. 4. Active HBV and HCV infection. 5. Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment. 7\. Prior failed CAR-T treatment.

Primary outcome measure(s)

Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion — 24 weeks
Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells in patients with relapsed B cell lymphoma (BCL) using CTCAE 4 standard to evaluate the level of adverse events

Trial sites (1)

Facility	City	Region	Status
Shenzhen Geno-Immune Medical Institute	Shenzhen	Guangdong

More Shenzhen Geno-Immune Medical Institute trials in China

Immunotherapy Treating GI Cancer Starting soon

Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma Starting soon

DLL3 CAR-T Therapy Targeting Brain Tumors Starting soon

cfMSC Stem Cell Therapy Targeting COPD Starting soon

Combination Immunotherapy Targeting Sarcomas Starting soon

Other trials for the same condition

Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04429438 on ClinicalTrials.gov ↗ ← All trials in China