Actively Recruiting
A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors
Led by YANRU WANG · Updated on 2025-07-10
21
Participants Needed
1
Research Sites
138 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
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
Official 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...
- Willing to participate and able to provide signed informed consent
- Diagnosed with B-lymphocyte or plasma cell-derived malignancies according to 2017 WHO criteria, including B-ALL, DLBCL, FL, MZL, SLL/CLL, MCL, and multiple myeloma
- Disease is refractory or has recurred after standard treatment, or persistent minimal residual disease after hematologic remission in B-cell ALL
- Relapsed/refractory lymphoma patients must have at least one measurable lesion 1.5 cm or larger
- Age 18 years or older, any gender
- Expected survival of at least 12 weeks
- Total bilirubin less than twice the upper limit of normal, creatinine below the upper limit of normal, ALT and AST less than three times the upper limit of normal
- Absolute neutrophil count at least 0.5 x 10^9/L and platelets at least 20 x 10^9/L; no blood count requirements for B-lymphocyte malignancies with bone marrow involvement
- ECOG performance status of 0 to 2
- Left ventricular ejection fraction of 50% or higher with no pericardial effusion
- At least 2 weeks since last treatment such as radiotherapy, chemotherapy, or monoclonal antibody therapy
You will not qualify if you...
- Allergies, hypersensitivity, or intolerance to CD19/BCMA allogenic CAR-T or components including fludarabine, cyclophosphamide, or rituximab
- Recurrence after allogeneic stem cell transplant with active graft-versus-host disease requiring steroids or immunosuppressants
- Severe active infections
- Acquired or congenital immunodeficiency
- NYHA 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 non-melanoma skin cancer or cured carcinoma in situ
- Use of 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 the investigator believes increases risk or interferes with the study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212001
Actively Recruiting
Research Team
X
Xiaoming Fei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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