B Cell Lymphoma, Multiple Myeloma
Conditions
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.
Interventions
DRUGRN1101 injection
RN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously.
Sponsors
Rui Therapeutics Co., Ltd
Allorunning Therapeutics
YANRU WANG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events after RN1101 infusion | up to 24 weeks after RN1101 infusion |
Secondary
| Measure | Time frame |
|---|---|
| ORR (PR, VGPR, CR and sCR) of patients receive RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| Progression free survival after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| Percentage of MRD negative patients after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| Duration of response after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| Overall survival after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
| CAR copies and cell count of CAR-T in blood and bone marrow (if available) after RN1101 treatment | 12 weeks, 24 weeks after RN1101 infusion |
Countries
China
Contacts
Primary ContactXiaoming Fei
Outcome results
None listed