BCMA-CD19 cCAR T cells
BiologicalBCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy
NCT Number: NCT04162353
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.
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Interventional
Phase 1
Peking University Shenzhen Hospital, China, Shenzhen, Guangdong, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy
Time frame: 2 years particularly the first 28 days after infusion
Determine the toxicity profile of BCMA-CD19 cCAR T cell therapy
Time frame: up to 6 months
Incidence of treatment-emergent adverse events
Time frame: 24 months
Stringent complete response (sCR) (IMWG criteria)
Time frame: 24 months
Complete response (CR) (IMWG criteria)
Time frame: 24 months
Very good partial response (VGPR) (IMWG criteria)
Time frame: 24 months
Partial response (PR) (IMWG criteria)
Time frame: 24 months
Minimal response (MR) (IMWG criteria)
Time frame: 24 months
Stable disease (SD) (IMWG criteria)
Time frame: 12 months
Progressive disease (PD) (IMWG criteria)
Time frame: up to 24 months
Progression-free survival (PFS) (IMWG criteria)
Time frame: 1 year
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival
Contact information is provided by the study sponsor or research team.
iCell Gene Therapeutics
Industry
BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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