Status:
RECRUITING
A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors
Lead Sponsor:
YANRU WANG
Collaborating Sponsors:
Rui Therapeutics Co., Ltd
Allorunning Therapeutics
Conditions:
B Cell Lymphoma
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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/ref...
Eligibility Criteria
Inclusion
- Willingness to participate in the trial and provision of signed informed consent.
- 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.
- 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.
- Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
- 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.
- 18 Years and older, regardless of gender.
- An expected survival of ≥12 weeks.
- 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.
- 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.
- ECOG performance status of 0 - 2.
- Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion.
- At least 2 weeks have passed since the last treatment (radiotherapy, chemotherapy, monoclonal antibody therapy, or other treatments).
Exclusion
- 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.
- Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
- Severe active infection.
- Acquired or congenital immunodeficiency.
- New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
- History of epilepsy or other central nervous system diseases.
- Lymphoma with extranodal involvement of the brain, lungs, or gastrointestinal tract.
- Other primary cancers, except:
- Non-melanoma skin cancer (e.g., basal cell carcinoma) cured by resection.
- Carcinoma in situ (e.g., cervical, bladder, or breast cancer) cured.
- Systemic high-dose steroids within 2 weeks before treatment.
- Pregnant, breastfeeding, or plans to become pregnant within 6 months.
- Participation in another clinical trial within the past month.
- Any situation the investigator deems may raise risks or interfere with trial results.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06976437
Start Date
May 6 2025
End Date
December 30 2027
Last Update
July 10 2025
Active Locations (1)
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1
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212001