4SCAR-T Therapy Post CD19-targeted Immunotherapy

ConditionCD19 Negative B-cell Malignancies

Trial statusRecruiting

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 (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation 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.

B cell malignancies relapsed after anti-CD19 immunotherapy.

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

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.

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

Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20
Biological/Vaccine
Patients who have relapsed after anti-CD19 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 infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells

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

Time frame

24 weeks

Secondary outcomes

Anti-tumor activity of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells

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

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