Dual-target BCMA–CD19 CAR T-cell therapy for relapsed or refractory multiple myeloma and plasmacytoid lymphoma
Official title: BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma
Run by iCell Gene Therapeutics · NCT04162353 · Data updated 2026-11-12
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 |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | iCell Gene Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, CAR T, Chimeric Antigen Receptor, immunotherapy |
| Locations | 2 sites (Shenzhen, Guangdong and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2019 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT04162353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
LB-208: a new oral treatment for adults with advanced solid tumors or lymphoma
This early study tests whether LB-208, taken once daily by mouth, is safe for adults with advanced solid tumors or lymphoma who have exhausted standard treatments.
-
Tailored exercise program to improve quality of life for adults with hematologic cancers
This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.
-
In Vivo BCMA-CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
This study tests VV169, a one-time in vivo CAR-T treatment, in adults with multiple myeloma that has come back or not responded to standard therapy.
-
CD19/CD22 CAR-T consolidation after second-line therapy for high-risk aggressive B-cell lymphoma
This trial tests whether CD19/CD22 CAR-T cell therapy given after a second-line response can help people with high-risk aggressive B-cell lymphoma stay in remission.
-
Inobrodib with Pomalidomide and Dexamethasone vs Standard Therapy for Relapsed or Refractory Myeloma
This study tests whether inobrodib with pomalidomide and dexamethasone helps people with relapsed or refractory multiple myeloma more than the standard available therapy.
-
Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia
This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.