BCMA-CS1 Compound CAR (cCAR) T Cells for Relapsed/Refractory Multiple Myeloma
Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of BCMA-CS1 cCAR in Patients With Relapsed and/or Refractory Multiple Myeloma
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-CS1 cCAR in patients with relapsed and/or refractory multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 multiple-myeloma
Started Aug 2018
Typical duration for early_phase_1 multiple-myeloma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2018
CompletedFirst Submitted
Initial submission to the registry
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedNovember 12, 2019
January 1, 2019
3 years
November 6, 2019
November 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
28 days
Type of dose-limiting toxicity (DLT)
28 days
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
2 years
Secondary Outcomes (3)
Overall Response Rate (ORR)
1 year
Progression-free survival (PFS)
1 year
Overall survival
1 year
Study Arms (1)
BCMA-CD33 cCAR T cells
EXPERIMENTALBCMA-CS1 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-BCMA and CS1 CARs
Interventions
BCMA-CS1 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:
- Diagnosis 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 4 weeks
- Female must be not pregnant during the study
You may not qualify if:
- Prior solid organ transplantation
- Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iCell Gene Therapeuticslead
- Peking University Shenzhen Hospitalcollaborator
- Chengdu Military General Hospitalcollaborator
- iCAR Bio Therapeutics Ltd.collaborator
Study Sites (2)
Chengdu Military General Hospital
Chengdu, China
Peking University Shenzhen Hospital
Shenzhen, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongyu Zhang, MD, PhD
Peking University Shenzhen Hospital
- PRINCIPAL INVESTIGATOR
Fang Liu, MD, PhD
Chengdu Military General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2019
First Posted
November 7, 2019
Study Start
August 31, 2018
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
November 12, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share