An Investigator-initiated Trial to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of Relapsed/Refractory(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia(B-ALL)

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 site in 1 country30 target enrollmentDecember 5, 2022

ConditionsB-cell Acute Lymphoblastic Leukemia B-ALL

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-cell Acute Lymphoblastic Leukemia
Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Enrollment: 30
Locations: 1
Primary Endpoint: Dose-limiting toxicity (DLT)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of UCAR-T Cells injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).

Detailed Description

Although the anti-CD19 CAR-T cell therapies have gained significant clinical outcome in patients with r/r B-ALL，autologous CAR-T is not feasible for some patients. To make further improvement, the investigators are going to conduct a clinical trial using universal CAR-T(UCAR-T) cells targeting CD19 for r/r B-ALL patients. After enrollment, patients will get a 3-5 days lymphodepletion therapy, then the UCAR-T 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

December 5, 2022

End Date

December 31, 2025

Last Updated

3 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

•Male or female, aged 2-75 years;
•A definite diagnosis of relapsed/refractory B-ALL and a percentage of primitive/naive lymphocytes \>5% in bone marrow at baseline (flow cytometry);
•CD19 expression was positive in bone marrow or peripheral blood tumor cells;
•ECOG score 0-2 points;
•Expected survival time ≥3 months;
•Adequate liver, kidney, heart and lung function;
•Patients who have recovered from acute toxic effects of prior chemotherapy should be excluded from the trial at least one week apart;
•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;
•Voluntarily sign the informed consent.

Exclusion Criteria

•Presence of other concurrent active malignancy;
•People with severe mental disorders;
•A 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;
•Had 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;
•A history or disease of the central nervous system(CNS), such as seizure disease, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
•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;