Actively Recruiting
BCMA-CD19 cCAR in Relapsed and/or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
Led by iCell Gene Therapeutics · Updated on 2025-09-16
12
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
I
iCell Gene Therapeutics
Lead Sponsor
I
iCAR Bio Therapeutics Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of BCMA-CD19 cCAR, a new type of immunotherapy, in patients with relapsed or refractory multiple myeloma and plasmacytoid lymphoma. This phase I, single-arm, open-label study investigates a compound Chimeric Antigen Receptor (cCAR) therapy designed to target two proteins, BCMA and CD19, on cancer cells. The treatment aims to address the challenges of tumor heterogeneity and resistance in these diseases by attacking both myeloma and lymphoma cells with dual-targeted CAR T-cells. The treatment involves administering BCMA-CD19 cCAR T cells, which are genetically modified T cells expressing receptors against BCMA and CD19. These cells are given intravenously after patients receive lymphodepleting chemotherapy. The study includes a dose escalation phase, starting from 2 million to 10 million CAR T cells per kilogram of body weight, to find the most suitable dose. Both fresh and thawed CAR T cells may be used during infusion. Participants will be closely monitored for adverse events, especially within the first 28 days after infusion and up to two years. Researchers will track treatment-emergent side effects for up to six months. The study requires informed consent and involves assessments of safety and tolerability. Overall participation duration and follow-up visits will ensure careful evaluation of the treatment's effects over time.
CONDITIONS
Brief Title
BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent to participate in the study
- Diagnosis based on World Health Organization (WHO) 2008 criteria
- Patients have exhausted standard therapeutic options
- Immunosuppressive drugs or corticosteroids stopped for more than 1 week
- Female participants must not be pregnant during the study
You will not qualify if you...
- Declining consent for treatment
- Prior solid organ transplantation
- Prior potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Previous treatment with BCMAxCD3 or CD19xCD3 bispecific agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion with monitoring during the first 28 days
Participants receive BCMA-CD19 cCAR T cells after lymphodepleting chemotherapy to target multiple myeloma and plasmacytoid lymphoma.
1 infusion visit and multiple follow-up visits during the first 28 days
Duration - Up to 6 months
Participants are monitored for adverse events and safety outcomes up to 6 months after treatment.
Regular follow-up visits during 6 months
Trial Site Locations
Total: 2 locations
1
Peking University Shenzhen Hospital, China
Shenzhen, Guangdong, China
Actively Recruiting
2
Chengdu Military General Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
K
Kevin Pinz, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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