RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Aug 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment called Allogeneic CAR-T (UCAR-T) cell therapy for adults with certain blood cancers that have come back or did not respond to previous treatments. These cancers include types like multiple myeloma, some kinds of leukemia, and lymphoma. The treatment involves giving patients a special immune cell therapy after preparing their body with medicines to help the new cells work better. The goal is to see if this treatment is safe and if it helps control or reduce the cancer.

Adults 18 years and older with specific types of blood cancer that test positive for certain markers (called CD19 or BCMA) and who have not had success with standard treatments may be eligible. Patients need to have measurable disease, meaning doctors can track the cancer’s response to treatment, and they must be well enough to participate based on heart, liver, kidney function, and overall health. Participants will receive one infusion of the UCAR-T cells and will be closely monitored for how well the treatment works and any side effects. This trial is currently not yet recruiting, and it focuses on understanding how these special immune cells behave in the body and how safe and effective this new approach might be for patients with hard-to-treat blood cancers.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Voluntary participation with signed informed consent.
• • 2. 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.
• • 3. Relapsed/refractory disease defined as failure to achieve complete remission after standard therapy, or relapse after an initial response during treatment or follow-up.
• 4. Measurable disease required:
• • 1. For B-ALL: persistent minimal residual disease (MRD) positivity despite hematologic remission.
• • 2. For lymphoma: at least one measurable lesion ≥1.5 cm in longest diameter per IWG revised criteria.
• • 3. For multiple myeloma: positive immunofixation electrophoresis or presence of extramedullary disease.
• • 5. Age ≥18 years; both sexes eligible.
• • 6. Expected survival ≥12 weeks.
• 7. Adequate organ function (exceptions for disease-related impairment are at the investigator's discretion):
• • 1. Total bilirubin \<2× upper limit of normal (ULN); serum creatinine \<ULN; ALT and AST \<3× ULN.
• • 2. Absolute neutrophil count ≥0.5×10⁹/L; platelets ≥20×10⁹/L (no requirement if marrow involvement is documented).
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
• • 4. Left ventricular ejection fraction (LVEF) ≥50%.
• • Exclusion Criteria
• • 1. Known hypersensitivity, allergy, intolerance, or contraindication to CD19/BCMA-UCAR-T or any study drugs (fludarabine, cyclophosphamide, tocilizumab).
• • 2. Genetic syndromes: Fanconi, Kostmann, Shwachman, or any documented bone-marrow failure syndrome.
• • 3. Active or uncontrolled infection requiring IV antibiotics; evidence of severe active infection.
• • 4. NYHA Class III or IV heart failure (unless clearly secondary to the underlying malignancy).
• • 5. Central Nervous System (CNS) disorders unrelated to the primary hematologic malignancy.
• • 6. Prior malignancy except adequately treated carcinoma in situ of skin, cervix, lung, or other non-active tumors.
• • 7. Significant bleeding diathesis (e.g., gastrointestinal (GI) bleeding, coagulopathy, hypersplenism).
• • 8. History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation..
• • 9. Pregnancy, lactation, or planned pregnancy within 6 months.
• • 10. Any condition that, in the investigator's opinion, may increase risk or interfere with study results.