Allogeneic CD19/BCMA CAR-T for relapsed or refractory B-cell and plasma cell cancers

An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CD19/BCMA CAR-T Cell Treatment for Relapsed/ Refractory B-cell or Plasma Cell-derived Malignant Tumors

This study will test whether an off-the-shelf CAR-T product (RN1101) that targets CD19 and BCMA can help people with relapsed or refractory B-cell lymphomas and multiple myeloma.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Affiliated Hospital of Jiangsu University (Academic / other)
• Drugs / interventions: rituximab, CAR-T, chemotherapy, cyclophosphamide, fludarabine
• Locations: 1 site (Zhenjiang, Jiangsu)
• Trial ID: NCT06976437 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label dose-escalation pilot that plans to enroll about 21 patients with relapsed or refractory B-cell or plasma cell–derived malignancies. Participants receive an allogeneic CAR-T product (RN1101) engineered to target both CD19 and BCMA and are monitored closely for safety, cell expansion, persistence and antigen depletion. The primary goal is to test safety and feasibility, with secondary endpoints focused on clinical responses and exploratory endpoints assessing CAR-T kinetics and target cell clearance. The protocol includes standard toxicity monitoring and scheduled on-site follow-up visits to document adverse events and efficacy signals.

Who should consider this trial

Good fit: Ideal candidates are patients with relapsed or refractory B-cell or plasma cell malignancies (including DLBCL, FL, MZL, SLL/CLL, MCL, B-ALL with MRD, or multiple myeloma) who have failed standard therapies and can give informed consent.

Not a fit: Patients whose tumors lack CD19 or BCMA expression, who have uncontrolled infections or severe organ dysfunction, or who are too frail for CAR-T infusion are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, RN1101 could provide an off-the-shelf dual-target CAR-T option that achieves remissions in patients with relapsed or refractory B-cell and plasma cell malignancies.

How similar studies have performed: Autologous CD19 and BCMA CAR-T therapies have produced strong responses in these cancers, but allogeneic dual-target CAR-T approaches like RN1101 remain early and less proven in clinical studies.

Eligibility criteria

Inclusion Criteria:

1. Willingness to participate in the trial and provision of signed informed consent.
2. Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic leukemia (B-ALL), and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle cell lymphoma (MCL), multiple myeloma (MM), etc.
3. Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line or salvage therapy.
4. Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
5. According to the revised International Working Group (IWG) criteria, relapsed/refractory lymphoma patients must have at least one measurable lesion with a longest diameter ≥1.5 cm.
6. 18 Years and older, regardless of gender.
7. An expected survival of ≥12 weeks.
8. Serum total bilirubin level \< twice the upper limit of normal, serum creatinine level \< upper limit of normal, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< three times the upper limit of normal.
9. Absolute neutrophil count ≥0.5×10⁹/L, platelets ≥20×10⁹/L; for B-lymphocyte malignancies with definitive bone marrow involvement, no requirements for neutrophil and platelet counts.
10. ECOG performance status of 0 - 2.
11. Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion.
12. At least 2 weeks have passed since the last treatment (radiotherapy, chemotherapy, monoclonal antibody therapy, or other treatments).

Exclusion Criteria:

1. Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe allergic reactions.
2. Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
3. Severe active infection.
4. Acquired or congenital immunodeficiency.
5. New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
6. History of epilepsy or other central nervous system diseases.
7. Lymphoma with extranodal involvement of the brain, lungs, or gastrointestinal tract.
8. Other primary cancers, except:

   1. Non-melanoma skin cancer (e.g., basal cell carcinoma) cured by resection.
   2. Carcinoma in situ (e.g., cervical, bladder, or breast cancer) cured.
9. Systemic high-dose steroids within 2 weeks before treatment.
10. Pregnant, breastfeeding, or plans to become pregnant within 6 months.
11. Participation in another clinical trial within the past month.
12. Any situation the investigator deems may raise risks or interfere with trial results.

Where this trial is running

Zhenjiang, Jiangsu

• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiaoming Fei

Conditions B Cell Lymphoma; Multiple Myeloma