Actively Recruiting
Exploratory Study on Allogeneic CD19/BCMA CAR-T Cell Treatment Safety and Efficacy for Relapsed/Refractory B-cell or Plasma Cell Malignant Tumors
Led by YANRU WANG · Updated on 2025-07-10
21
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
Y
YANRU WANG
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
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 treatment's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intravenous infusion of RN1101, an allogeneic CAR-T cell therapy targeting CD19 and BCMA.
1 infusion visit
Duration - Up to 24 weeks after infusion
Participants are monitored for safety and efficacy outcomes after the RN1101 infusion.
Visits at 12 and 24 weeks after infusion
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212001
Actively Recruiting
Research Team
X
Xiaoming Fei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here