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

NCT07113496 | Not Yet Recruiting Phase 1

• 1 other identifier: RN1201-Onc
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed or Refractory B-cell Hematologic Malignancies; B-cell Acute Lymphoblastic Leukemia (B-ALL); Multiple Myeloma (MM); Plasmablastic Lymphoma; Relapsed or Refractory CD19+/BCMA+ Hematologic Malignancies; Mature B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)

  TEAEs and DLTs will be graded according to CTCAE v5.0 and ASTCT consensus criteria

  DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Week 4, Month 3, Month 6 and Month 12

• Disease control rate (DCR)

  Week 4, Month 3, Month 6 and Month 12

• Progression-free survival (PFS)

  Week 4, Month 3, Month 6 and Month 12

• Overall survival (OS)

  Week 4, Month 3, Month 6 and Month 12

• Cmax of RN1201

  Up to 12 months

Study Arms (1)

Allogeneic CAR-T cell therapy

EXPERIMENTAL

RN1201 cells injection will be infused via intravenously

Biological: Allogeneic CAR-T

Interventions

Allogeneic CAR-T BIOLOGICAL

Patients will receive lymphodepletion chemotherapy followed by a single intravenous infusion of Allogeneic CAR-T cells. In select cases, CAR-T infusion may be administered post-autologous hematopoietic stem cell transplantation (auto-HSCT)

Allogeneic CAR-T cell therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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..
• Pregnancy, lactation, or planned pregnancy within 6 months.
• Any condition that, in the investigator's opinion, may increase risk or interfere with study results.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma; Multiple Myeloma; Plasmablastic Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoma, Large B-Cell, Diffuse

Study Officials

• Lei Fan

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Fan

CONTACT

086+025-68306124; fanlei@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma center

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)