OncoMatch/Clinical Trials/NCT06976437
A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors
Is NCT06976437 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies RN1101 for b cell lymphoma.
Treatment: RN1101 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard treatment
failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line or salvage therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation with active GVHD requiring steroid or immunosuppressive therapy
Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy
Lab requirements
Blood counts
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
Kidney function
serum creatinine level < upper limit of normal
Liver function
Serum total bilirubin level < twice the upper limit of normal, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < three times the upper limit of normal
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion
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. Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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