Combination CAR-T Cell Therapy Targeting Hematological Malignancies

ConditionB-cell Malignancies

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age6-75

SponsorShenzhen Geno-Immune Medical Institute

About this trial

The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. 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.

malignant B cell surface expression of CD19/CD20/CD22/CD30/CD38/CD70/CD123 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, the treatment is difficult to assess patient response.

bacteria, fungus, or virus 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 4SCAR22
Biological/Vaccine
4SCAR19 and 4SCAR22
4SCAR19 and 4SCAR38
Biological/Vaccine
4SCAR19 and 4SCAR38
4SCAR19 and 4SCAR20
Biological/Vaccine
4SCAR19 and 4SCAR20
4SCAR19 and 4SCAR123
Biological/Vaccine
4SCAR19 and 4SCAR123
4SCAR19 and 4SCAR70
Biological/Vaccine
4SCAR19 and 4SCAR70
4SCAR19 and 4SCAR30
Biological/Vaccine
4SCAR19 and 4SCAR30

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: 4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

Safety of fourth generation anti CD19 and CD20/CD22/CD30/CD38/CD70/CD123 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events

physiological parameter (for safety, measuring cytokine response, fever, symptoms)

Time frame

24 weeks

Secondary outcomes

Anti tumor activity of fourth generation anti CD19 and CD20/CD22/CD30/CD38/CD70/CD123 CAR-T cells in patients with relapsed or refractory B cell malignancies

scale of CAR copies and leukemic cell burden (for efficacy)

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

Apply now