NCT06662227

Universal CAR-T Cells (REVO-UWD-19) for Refractory and Relapsed B-Cell Tumors

A Clinical Study Evaluating the Safety and Efficacy of Universal CD19-Targeted CAR-T (UWD-CD19) Therapy for Refractory and Relapsed B-Cell Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wondercel Biotech (ShenZhen) · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, single-center, investigator-initiated clinical trial. The primary objective is to evaluate the safety and preliminary efficacy of administering universal CD19 CAR-T cells to subjects with refractory and relapsed B-cell tumors. Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of universal UWD-19 to assess its safety and efficacy. Subjects will be hospitalized for a period, and after discharge, they will undergo periodic efficacy assessments and long-term survival follow-up for at least five years.

Detailed description

This study is a single-arm clinical trial evaluating the universal CD19-targeted CAR-T cell therapy (UWD-CD19) in treating relapsed and refractory B-cell tumors. Initiated by investigators, the study aims to assess the safety and preliminary efficacy of this cell therapy, providing new therapeutic options for patients with B-cell tumors-a class of hematologic malignancies that often recur and resist standard treatments, posing substantial treatment challenges. CD19 is a specific marker predominantly expressed on the surface of B-cells, making it a prime target for CAR-T cell therapies. CAR-T therapy involves extracting T cells from a healthy donor and genetically engineering them to recognize and attack CD19-expressing tumor cells. UWD-CD19, a "universal" CAR-T cell product, seeks to enhance therapy adaptability, allowing it to effectively target B-cell tumors across different patient groups. Study Objectives The primary objective of this study is to observe the therapeutic response in patients with relapsed or refractory B-cell tumors through a single infusion of UWD-CD19, specifically focusing on safety, tolerability, and preliminary efficacy. The research team will also conduct long-term follow-up on patients to assess the durability of treatment effects and survival rates, providing data support for the potential wider application of this novel therapy. Inclusion Criteria: Patients aged between 3 and 70, with no gender restrictions, must meet diagnostic criteria for B-cell lymphoma with CD19-positive tumor cells. Patients should have an evaluable or measurable lesion as defined by the 2014 Lugano criteria. Preconditioning: Eligible patients will receive lymphodepleting chemotherapy with Fludarabine and Cyclophosphamide before cell infusion to suppress the immune system and optimize CAR-T cell performance. CAR-T Cell Infusion: Patients will receive a one-time infusion of UWD-CD19 cells, and their responses will be closely monitored during and after infusion to ensure safety. Follow-up and Efficacy Assessment: Following treatment, patients will be hospitalized for a period and, after discharge, return regularly for follow-up and efficacy evaluations. The research team will conduct survival monitoring for at least five years. Inclusion and Exclusion Criteria To ensure the study's safety and scientific rigor, strict inclusion and exclusion criteria are set. Patients must meet requirements across age, pathology, disease stage, and organ function, and should not have other severe health conditions (e.g., active CNS involvement, severe cardiovascular disease, serious infections) that could confound efficacy assessments or increase patient risk. Potential Impact If results demonstrate good safety and efficacy of UWD-CD19 cell therapy in patients with relapsed and refractory B-cell tumors, this could open a new treatment pathway for this patient population. Universal CAR-T cell therapy could eventually extend to more hematologic malignancies, offering hope and support to patients facing significant treatment barriers. Ethics and Risk Management The study has been approved by the Medical Ethics Committee, and the research team will strictly adhere to ethical standards, ensuring patients provide informed consent and receive adequate medical support. Since CAR-T therapy may present potential side effects (e.g., cytokine release syndrome, neurotoxicity), patients will be under real-time monitoring, with prompt intervention provided as needed. This study aims to provide new insights and therapeutic approaches for B-cell tumor treatment through an in-depth evaluation of UWD-CD19 cell therapy. The research team will continue observing and recording patients' responses, establishing a scientific foundation for future immunotherapies in oncology and offering patients the prospect of long-term health benefits and quality of life improvements.

Conditions

• B Cell Lymphoma
• B Cell Leukemia
• B Cell Malignancy

Interventions

Type	Name	Description
BIOLOGICAL	Single dose injection of certain dose of UWD-19	Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of certain dose of universal UWD-19 cells
DRUG	MMF Immunosuppression	One day after the completion of fludarabine preconditioning (D-2), initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID) for 15 consecutive days, or extend the duration appropriately based on CAR-T cell expansion status (discontinuation may occur at the end of CAR-T cell expansion or on the day of patient discharge). The maximum duration of administration must not exceed 30 days.

Timeline

• Start date: 2024-10-24
• Primary completion: 2027-12-30
• Completion: 2029-12-30
• First posted: 2024-10-28
• Last updated: 2026-01-20

Locations

1 site across 1 country: China