BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

Phase

Condition

Leukemia

Cancer

Cancer/tumors

Treatment

BCMA-CD19 cCAR T cells

Clinical Study ID

NCT04162353

ICG185-001

All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 stoppedfor more than 1 weeks
Female must be not pregnant during the study

Exclusion

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

Study Design

BCMA-CD19 cCAR T cells

July 01, 2019

July 31, 2026

Study 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.

Connect with a study center

Peking University Shenzhen Hospital, China
Shenzhen, Guangdong
China
Site Not Available
Peking University Shenzhen Hospital, China
Shenzhen 1795565, Guangdong 1809935
China
Active - Recruiting
Chengdu Military General Hospital
Chengdu, Sichuan
China
Site Not Available
Chengdu Military General Hospital
Chengdu 1815286, Sichuan 1794299
China
Active - Recruiting

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