Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04162353

BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
12 (estimated)
Sponsor
iCell Gene Therapeutics · Industry
Sex
All
Age
—
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBCMA-CD19 cCAR T cellsBCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

Timeline

Start date
2019-07-01
Primary completion
2026-07-01
Completion
2026-07-01
First posted
2019-11-14
Last updated
2025-09-16

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT04162353. Inclusion in this directory is not an endorsement.