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)

Kunming Hope of Health Hospital1 site in 1 countryOctober 1, 2022

ConditionsB-cell Acute Lymphoblastic Leukemia B-ALL

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-cell Acute Lymphoblastic Leukemia
Sponsor: Kunming Hope of Health Hospital
Locations: 1
Primary Endpoint: Dose-limiting toxicity (DLT)
Status: Withdrawn
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 LstCAR019 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 cells(LstCAR019) targeting CD19 for r/r B-ALL patients. After enrollment, patients will get a 3-5 days lymphodepletion therapy, then the LstCAR019 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

October 1, 2022

End Date

October 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kunming Hope of Health Hospital

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;