RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
China27 participantsStarted 2025-08
Plain-language summary
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntary participation with signed informed consent.
. Pathologically confirmed CD19-positive and/or B-cell maturation antigen (BCMA)-positive hematologic malignancy according to the WHO 2017 classification, including but not limited to multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), mature B-cell lymphomas, and plasmablastic lymphoma.
. Relapsed/refractory disease defined as failure to achieve complete remission after standard therapy, or relapse after an initial response during treatment or follow-up.
. For lymphoma: at least one measurable lesion ≥1.5 cm in longest diameter per IWG revised criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
Timeframe: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.
Trial details
NCT IDNCT07113496
SponsorThe First Affiliated Hospital with Nanjing Medical University
. For multiple myeloma: positive immunofixation electrophoresis or presence of extramedullary disease.
. Age ≥18 years; both sexes eligible.
Exclusion criteria
. Known hypersensitivity, allergy, intolerance, or contraindication to CD19/BCMA-UCAR-T or any study drugs (fludarabine, cyclophosphamide, tocilizumab).
. Genetic syndromes: Fanconi, Kostmann, Shwachman, or any documented bone-marrow failure syndrome.
. Active or uncontrolled infection requiring IV antibiotics; evidence of severe active infection.
. NYHA Class III or IV heart failure (unless clearly secondary to the underlying malignancy).
. Central Nervous System (CNS) disorders unrelated to the primary hematologic malignancy.
. Prior malignancy except adequately treated carcinoma in situ of skin, cervix, lung, or other non-active tumors.
. History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation..