BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

iCell Gene Therapeutics

Status and phase: Unknown; Phase 1

Conditions: Multiple Myeloma in Relapse; Refractory Multiple Myeloma; Plasmacytoid; Lymphoma

Treatments: Biological: BCMA-CD19 cCAR T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04162353

ICG185-001

Details and patient eligibility

About

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.

Full description

BCMA-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressing on a T-cell, directed against the surface proteins BCMA and CD19. BCMA-CD19 cCAR is also aimed to treat multiple myeloma, a challenging disease due to the heterogeneity of myeloma cells, which renders single-antigen targeting CAR T-cell therapy ineffective. BCMA-CD19 cCAR is proposed to target both bulky myeloma cells expressing BCMA, and myeloma stem cells expressing CD19 to effectively eradicate the disease.

BCMA-CD19 cCAR is also aimed to treat heterogeneous plasmacytoid lymphoma bearing two types of lymphoma cells, regular lymphoma cells expressing CD19 and plasmacytoid lymphoma cells expressing BCMA. The use of two different targets intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape.

Enrollment: 12 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent; Patients volunteer to participate in the research
• Diagnosis is mainly based on the World Health Organization (WHO) 2008
• Patients have exhausted standard therapeutic options
• Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
• Female must be not pregnant during the study

Exclusion criteria

• Patients declining to consent for treatment
• Prior solid organ transplantation
• Potentially curative therapy including chemotherapy or hematopoietic cell transplant
• Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

BCMA-CD19 cCAR

Experimental group

Description:

Dose escalation phase: BCMA-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of BCMA and CD19 CARs on a T cell with an escalation approach, 2e6 to 10e6 CAR-T cells/kg

Treatment:

Biological: BCMA-CD19 cCAR T cells