BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? BCMA-CD19 cCAR T cells
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Chengdu Military General Hospital
RECRUITING
Chengdu
Peking University Shenzhen Hospital, China
RECRUITING
Shenzhen
Contact Information
Primary
Kevin Pinz, MS
kevin.pinz@icellgene.com
6315386218
Time Frame
Start Date: 2019-07-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 12
Treatments
Experimental: BCMA-CD19 cCAR
Dose 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
Related Therapeutic Areas
Sponsors
Collaborators: Peking University Shenzhen Hospital, iCAR Bio Therapeutics Ltd.
Leads: iCell Gene Therapeutics