NCT04162353 BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma
| NCT ID | NCT04162353 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | iCell Gene Therapeutics |
| Condition | Multiple Myeloma in Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2019-07-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2019-07-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hongyu Zhang, MD/PhD
PRINCIPAL INVESTIGATOR
Peking University Shenzhen Hospital, China
Frequently Asked Questions
Who can join the NCT04162353 clinical trial?
This trial is open to participants of all sexes, studying Multiple Myeloma in Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04162353 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04162353 currently recruiting?
Yes, NCT04162353 is actively recruiting participants. Contact the research team at kevin.pinz@icellgene.com for enrollment information.
Where is the NCT04162353 trial being conducted?
This trial is being conducted at Shenzhen, China, Chengdu, China.
Who is sponsoring the NCT04162353 clinical trial?
NCT04162353 is sponsored by iCell Gene Therapeutics. The principal investigator is Hongyu Zhang, MD/PhD at Peking University Shenzhen Hospital, China. The trial plans to enroll 12 participants.