CAR-T Immunotherapy Targeting CD19- ALL

ConditionB-cell Leukemia

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 will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age older than 6 months.

Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.

Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.

The KPS score over 80 points, and survival time is more than 1 month.

Disqualifiers

Complications with other active diseases, and difficult to assess patient response.

Bacteria, fungus, or virus infection, and unable to control.

Living with HIV.

Active HBV and HCV infection.

Trial design

Design model

Single group

Treatments tested in this trial

4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
Biological/Vaccine
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety of infusion

Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.

Time frame

24 weeks

Secondary outcomes

Anti-tumor activity of CART

Scale of CAR copies are detected by qPCR and leukemic cell burden are assessed by flow cytometry

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: