NCT05932173

A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies

An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Academic / Other
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.

Detailed description

OlyCAR is a novel CAR-T manufacturing system which allows to generate clinical-use CAR-T cells in short time. This study is going to evaluate the feasibility of CAR-T manufactured by OlyCAR platform in the treatment of B-Cell malignancies. The OlyCAR-019 cells will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.

Conditions

• B-Cell Leukemia
• B-Cell Lymphoma
• B-cell Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD19 Autologous CAR-T Cell Infusion	Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2023-07-06
• Last updated: 2023-07-11

Locations

1 site across 1 country: China