Multi-CAR-T Cells Targeting B Cell Lymphomas

ConditionB Cell Lymphoma (BCL)

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age6-75

SponsorShenzhen Geno-Immune Medical Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2
Biological/Vaccine
Patients who have relapsed and refractory B cell lymphoma (BCL) after conventional chemotherapy will be treated with multiple 4SCAR gene-engineered T cells

Treatment groups

11 Participants

are divided into 1 treatment group

Group A: 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion

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

Time frame

24 weeks

Secondary outcomes

Anti tumor activity of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion

Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: