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ACTIVE NOT RECRUITING
NCT07074496
EARLY_PHASE1

Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.

Official title: An Open, Prospective, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic Anti CD19 CAR-T Combined With a Novel Third-generation TKI Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-01-01

Completion Date

2028-07-01

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

DRUG

ThisCART19A

ThisCART19A is a new type CAR-T therapy for patients with ph+ ALL.

DRUG

Fludarabine

Fludarabine is used for lymphodepletion.

DRUG

Cyclophosphamide

Cyclophosphamide is used for lymphodepletion.

DRUG

Olverembatinib

a third-generation TKI

Locations (2)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, China