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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 (Jun 2026). This Early Phase 1 trial studies RN1101 for b cell lymphoma.

Early Phase 1RecruitingYANRU WANGNCT06976437Data as of Jun 2026Location: China

Treatment: RN1101A 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.

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Extracted eligibility criteria

Treatments studied

Other

RN1101

Cancer type

Non-Hodgkin Lymphoma

Multiple Myeloma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

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.

Frequently asked questions

Is NCT06976437 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic hematopoietic stem cell transplantation with active GVHD requiring steroid or immunosuppressive therapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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