Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
NCT07074496 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-07-20
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.
Conditions
- Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Interventions
- DRUG
-
ThisCART19A
ThisCART19A is a new type CAR-T therapy for patients with ph+ ALL.
- DRUG
-
Fludarabine is used for lymphodepletion.
- DRUG
-
Cyclophosphamide is used for lymphodepletion.
- DRUG
-
Olverembatinib
a third-generation TKI
Sponsors & Collaborators
-
Fundamenta Therapeutics, Ltd.
collaborator INDUSTRY -
The First Affiliated Hospital of Soochow University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2026-07-01
- Completion
- 2028-07-01
Countries
- China
Study Locations
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