CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies

iCell Gene Therapeutics

Status and phase: Unknown; Early Phase 1

Conditions: B Cell Leukemia; B Cell Lymphoma

Treatments: Biological: CD20-CD19 cCAR T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04156178

ICG133-001

Details and patient eligibility

About

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.

Full description

Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.

Enrollment: 12 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis based on the World Health Organization (WHO) 2008
2. Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL
3. Patients have exhausted standard therapeutic options
4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
5. Female must be not pregnant during the study

Exclusion criteria

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
4. Prior treatment with CD20xCD3 or CD19x3 bispecific agents

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

CD20-CD19 cCAR T cells

Experimental group

Description:

CD20-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD20 and CD19 CARs

Treatment:

Biological: CD20-CD19 cCAR T cells