Dual-target BCMA–CD19 CAR T-cell therapy for relapsed or refractory multiple myeloma and plasmacytoid lymphoma
BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
This treatment will try a dual-target CAR T-cell therapy that attacks BCMA and CD19 in people with relapsed or refractory multiple myeloma or plasmacytoid lymphoma who have exhausted standard options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Sex | All |
| Sponsor | iCell Gene Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, CAR T, Chimeric Antigen Receptor, immunotherapy |
| Locations | 2 sites (Shenzhen, Guangdong and 1 other locations) |
| Trial ID | NCT04162353 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, single-arm, open-label interventional study testing the safety and tolerability of BCMA–CD19 compound CAR (cCAR) T cells in patients with relapsed or refractory multiple myeloma and plasmacytoid lymphoma. The cCAR construct expresses two distinct functional CAR molecules on the same T cell to target BCMA on bulk myeloma/plasmacytoid cells and CD19 on stem-like or regular lymphoma cells. The dual-target approach is intended to broaden antigen coverage and reduce the chance of antigen escape that can cause relapse after single-antigen CAR T therapy. Patients are treated at participating hospitals in China and followed for safety and initial signs of anti-tumor activity.
Who should consider this trial
Good fit: Adults with relapsed or refractory multiple myeloma or plasmacytoid lymphoma who have exhausted standard therapies, can give informed consent, and meet the study's clinical eligibility criteria are appropriate candidates.
Not a fit: Patients who have curative treatment options available, prior BCMAxCD3 or CD19xCD3 bispecific therapy, recent solid organ transplant, or who cannot discontinue immunosuppression are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the dual-target cCAR could better eliminate heterogeneous tumor cells and lower the risk of relapse caused by antigen escape.
How similar studies have performed: BCMA-targeted CAR T therapies have produced high initial response rates in relapsed myeloma but antigen escape and relapse remain issues, and dual-target approaches like BCMA–CD19 are newer with limited but encouraging early data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shenzhen, Guangdong and 1 other locations
- Peking University Shenzhen Hospital, China — Shenzhen, Guangdong, China (Recruiting)
- Chengdu Military General Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Hongyu Zhang, MD/PhD — Peking University Shenzhen Hospital, China
- Study coordinator: Kevin Pinz, MS
- Email: kevin.pinz@icellgene.com
- Phone: 6315386218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.