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

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 site in 1 country60 target enrollmentJuly 1, 2023

ConditionsB-Cell Leukemia B-Cell Lymphoma B-cell Tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-Cell Leukemia
Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Enrollment: 60
Locations: 1
Primary Endpoint: Incidence of adverse events(AE) after infusion
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 1, 2023

End Date

June 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A definite diagnosis of relapsed/refractory B-cell malignancies;
•Male or female, aged 2-75 years;
•Confirmed detectable disease；
•Expected survival time \>12 weeks;
•Eastern cooperative oncology group (ECOG) score is 0-2;
•Adequate liver , kidney and cardiopulmonary function;
•Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up;
•Willingness to complete the informed consent process and to comply with study procedures and visit schedule.

Exclusion Criteria

•Presence of other concurrent active malignancy; People with severe mental disorders;
•History of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome;
•Acute GVHD of grade II-IV or extensive chronic GVHD;
•Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
•The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters;
•Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; Patients with severe history of allergy or allergic constitution;
•A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis);
•Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
•Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
•For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;