BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

Refractory Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162353
• Other study ID #: ICG185-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2021
• Est. completion date: September 2021

Study information

• Verified date: May 2021
• Source: iCell Gene Therapeutics
• Contact: Kevin Pinz, MS
• Phone: 6315386218
• Email: kevin.pinz[@]icellgene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Multiple Myeloma in Relapse
• Neoplasms, Plasma Cell
• Plasmacytoid; Lymphoma
• Refractory Multiple Myeloma

Intervention

Biological:
• BCMA-CD19 cCAR T cells
BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

Locations

Country	Name	City	State
China	Chengdu Military General Hospital	Chengdu	Sichuan
China	Peking University Shenzhen Hospital, China	Shenzhen	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
iCell Gene Therapeutics	iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	For multiple myeloma - Stringent complete response	Stringent complete response (sCR) (IMWG criteria)	24 months
Other	For multiple myeloma - Complete response (CR)	Complete response (CR) (IMWG criteria)	24 months
Other	For multiple myeloma - Very good partial response (VGPR)	Very good partial response (VGPR) (IMWG criteria)	24 months
Other	For multiple myeloma - Partial response (PR)	Partial response (PR) (IMWG criteria)	24 months
Other	For multiple myeloma - Minimal response (MR)	Minimal response (MR) (IMWG criteria)	24 months
Other	For multiple myeloma - Stable disease (SD)	Stable disease (SD) (IMWG criteria)	24 months
Other	For multiple myeloma - Progressive disease (PD)	Progressive disease (PD) (IMWG criteria)	12 months
Other	For multiple myeloma - Progression-free survival (PFS)	Progression-free survival (PFS) (IMWG criteria)	up to 24 months
Other	For plasmacytoid lymphoma - Assessment of morphologic CR, CR1, no residual disease, and molecular remission	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	1 year
Other	For plasmacytoid lymphoma - Progression-free survival (PFS)	Progression-free survival (PFS)	1 year
Other	For plasmacytoid lymphoma - Overall survival	Overall survival	1 year
Primary	Number of adverse events after BCMA-CD19 cCAR T cells infusion	Determine the toxicity profile of BCMA-CD19 cCAR T cell therapy	2 years particularly the first 28 days after infusion
Secondary	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events	up to 6 months