What is RN1101 studying for relapsed or refractory B-cell malignant tumors?

RN1101 is being studied as a treatment for relapsed or refractory B-cell and plasma cell-derived malignant tumors, such as lymphoma and multiple myeloma. The trial aims to evaluate the safety and feasibility of using these specialized CAR-T cells to target cancer cells. This research is sponsored by Yanru Wang and helps explore new options for patients with these difficult-to-treat cancers.

Who may be eligible for this B-cell lymphoma and multiple myeloma clinical trial?

Adults 18 years and older diagnosed with relapsed or refractory B-cell or plasma cell-derived malignancies may be eligible. Participants must have adequate organ function, an expected survival of at least 12 weeks, and no recent cancer treatments within 2 weeks. Both males and females can participate unless otherwise excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this B-cell lymphoma and multiple myeloma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan for potential costs related to getting to and from study visits.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

ID06976437

Study of Allogeneic CD19 and BCMA CAR-T Cell Therapy for Adults with Relapsed or Refractory B-cell or Plasma Cell Tumors Early Phase 1 Trial to Assess Safety and Effectiveness of RN1101 Treatment

Led by YANRU WANG · Updated on 2025-07-10

Participants Needed

Research Sites

32 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an investigational treatment called RN1101, which are allogeneic CAR-T cells targeting CD19 and BCMA. This early-phase, open-label pilot study focuses on patients with relapsed or refractory B-cell or plasma cell-derived malignant tumors, including B-cell lymphoma and multiple myeloma. The study plans to enroll 21 patients to understand how well this treatment works and its safety profile for these challenging cancers. Participants will receive a single intravenous infusion of RN1101 cells designed to target and attack cancerous B cells or plasma cells. The study involves a dose-escalation approach where all patients receive the experimental therapy. Researchers will monitor the treatments ability to reduce or eliminate cancer cells expressing CD19 or BCMA and evaluate how long these CAR-T cells persist in the body. Throughout the study, participants will be closely followed for up to 24 weeks after the infusion. Researchers will assess safety by tracking adverse events and measure effectiveness using outcomes such as minimal residual disease status, response rates, progression-free survival, overall survival, and CAR-T cell presence in blood and bone marrow. Blood tests, imaging, and clinical evaluations will be performed regularly to monitor treatment response and participant health over this period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Willingness to participate and provide signed informed consent
Diagnosed with B-lymphocyte or plasma cell-derived malignancies as defined by 2017 WHO criteria
Refractory or recurrent disease after standard treatment or relapse after remission
B-cell acute lymphoblastic leukemia patients with hematologic remission but persistent minimal residual disease
Relapsed/refractory lymphoma patients must have at least one measurable lesion 1.5 cm
Age 18 years or older, any gender
Expected survival of at least 12 weeks
Serum bilirubin less than twice the upper limit of normal; creatinine and liver enzymes within specified limits
Absolute neutrophil count 0.5 x 10^9/L and platelets 20 x 10^9/L; no count requirements if bone marrow involved
ECOG performance status 0 to 2
Left ventricular ejection fraction 50% or higher with no pericardial effusion
At least 2 weeks since last cancer treatment (radiotherapy, chemotherapy, monoclonal antibodies, or others)

You will not qualify if you...

Allergy or intolerance to CD19/BCMA CAR-T cells or trial drug components including fludarabine, cyclophosphamide, and rituximab
Active graft-versus-host disease after allogeneic stem cell transplant requiring steroids or immunosuppressants
Severe active infection
Acquired or congenital immunodeficiency
New York Heart Association Class II or III heart failure
History of epilepsy or other central nervous system diseases
Lymphoma involving brain, lungs, or gastrointestinal tract
Other primary cancers except cured non-melanoma skin cancer or carcinoma in situ
Systemic high-dose steroids within 2 weeks before treatment
Pregnant, breastfeeding, or planning pregnancy within 6 months
Participation in another clinical trial within the past month
Any condition that may increase risk or interfere with trial results as judged by investigator

Research Team

Xiaoming Fei

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