NCT07113496Not yet recruitingPhase 1
RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CAR-T Cell (RN1201) for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- Aug 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- NCT number
- NCT07113496
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 27
- From Aug 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Significant bleeding diathesis (e.g., gastrointestinal (GI) bleeding, coagulopathy, hypersplenism).
- History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation..
- Any condition that, in the investigator's opinion, may increase risk or interfere with study results.
Other
- Pregnancy, lactation, or planned pregnancy within 6 months.
Who the study is looking for
- 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.
- Measurable disease required:
- For B-ALL: persistent minimal residual disease (MRD) positivity despite hematologic remission.
- For lymphoma: at least one measurable lesion ≥1.5 cm in longest diameter per IWG revised criteria.
- For multiple myeloma: positive immunofixation electrophoresis or presence of extramedullary disease.
- Age ≥18 years; both sexes eligible.
- Expected survival ≥12 weeks.
- Adequate organ function (exceptions for disease-related impairment are at the investigator's discretion):
- Total bilirubin \<2× upper limit of normal (ULN); serum creatinine \<ULN; ALT and AST \<3× ULN.
- Absolute neutrophil count ≥0.5×10⁹/L; platelets ≥20×10⁹/L (no requirement if marrow involvement is documented).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
- Left ventricular ejection fraction (LVEF) ≥50%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.