BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

Phase 1

• Conditions: Refractory Multiple Myeloma; Multiple Myeloma in Relapse; Plasmacytoid; Lymphoma
• Interventions: Biological: BCMA-CD19 cCAR T cells

• Registration Number: NCT04162353
• Lead Sponsor: iCell Gene Therapeutics

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Status Verified: 2021-05
• Study Start: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-19
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BCMA-CD19 cCAR	BCMA-CD19 cCAR T cells	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

Primary Outcome Measures

Name	Time	Method
Number of adverse events after BCMA-CD19 cCAR T cells infusion	2 years particularly the first 28 days after infusion	Determine the toxicity profile of BCMA-CD19 cCAR T cell therapy

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	up to 6 months	Incidence of treatment-emergent adverse events

Trial Locations

Locations (2)

Peking University Shenzhen Hospital, China; 🇨🇳 Shenzhen, Guangdong, China

Chengdu Military General Hospital; 🇨🇳 Chengdu, Sichuan, China