A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors

NCT06976437 | Recruiting Early Phase 1

• 1 other identifier: RunNing
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

B Cell Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events after RN1101 infusion

  up to 24 weeks after RN1101 infusion

Secondary Outcomes (6)

• Percentage of MRD negative patients after RN1101 treatment

  12 weeks, 24 weeks after RN1101 infusion

• 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

• 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

• Duration of response after RN1101 treatment

  12 weeks, 24 weeks after RN1101 infusion

Study Arms (1)

RN1101 treatment

EXPERIMENTAL

CD19+ or BCMA+ r/r B Cell lymphoma or multiple myeloma (MM) patients to be treated with a single dose of RN1101 cells.

Drug: RN1101 injection

Interventions

RN1101 injection DRUG

RN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously.

RN1101 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• YANRU WANG: lead
• Rui Therapeutics Co., Ltd: collaborator
• Allorunning Therapeutics: collaborator

Study Sites (1)

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212001, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Central Study Contacts

Xiaoming Fei

CONTACT

+86-1381512462752; feixiaomingujs@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)