BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma
BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2019
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
September 16, 2025
September 1, 2025
7 years
November 11, 2019
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of treatment-emergent adverse events
up to 6 months
Other Outcomes (11)
For multiple myeloma - Stringent complete response
24 months
For multiple myeloma - Complete response (CR)
24 months
For multiple myeloma - Very good partial response (VGPR)
24 months
- +8 more other outcomes
Study Arms (1)
BCMA-CD19 cCAR
EXPERIMENTALDose 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
Interventions
BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iCell Gene Therapeuticslead
- iCAR Bio Therapeutics Ltd.collaborator
- Peking University Shenzhen Hospitalcollaborator
Study Sites (2)
Peking University Shenzhen Hospital, China
Shenzhen, Guangdong, China
Chengdu Military General Hospital
Chengdu, Sichuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongyu Zhang, MD/PhD
Peking University Shenzhen Hospital, China
- PRINCIPAL INVESTIGATOR
Fang Liu, MD/PhD
Chengdu Military General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2019
First Posted
November 14, 2019
Study Start
July 1, 2019
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share