NCT06976437 A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors
| NCT ID | NCT06976437 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | YANRU WANG |
| Condition | B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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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 21 participants in total. It began in 2025-05-06 with a primary completion date of 2027-05-20.
⚠ 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
A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06976437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B Cell Lymphoma. 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 NCT06976437 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 NCT06976437 currently recruiting?
Yes, NCT06976437 is actively recruiting participants. Contact the research team at feixiaomingujs@aliyun.com for enrollment information.
Where is the NCT06976437 trial being conducted?
This trial is being conducted at Zhenjiang, China.
Who is sponsoring the NCT06976437 clinical trial?
NCT06976437 is sponsored by YANRU WANG. The trial plans to enroll 21 participants.