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

NCT07074496 | Active Not Recruiting Early Phase 1

• 1 other identifier: ThisCART19A Ph+ALL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Complete Molecular Remission

  Will be estimated along with the 95% credible intervals. Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.

  4 weeks

• Incidence of adverse events (AEs)

  Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.

  2 years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  2 years

• Duration of Complete Molecular Remission

  From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 years.

• Event-free survival (EFS)

  From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years

• Overall survival (OS)

  From the first day of treatment to time of death from any cause, assessed up 2 years

Study Arms (1)

Treatment Group

EXPERIMENTAL

ThisCART19A cells infusion, Given intravenously，Combined With Olverembatinib, Given PO

Drug: ThisCART19A; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Olverembatinib

Interventions

ThisCART19A DRUG

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

Treatment Group

Fludarabine DRUG

Fludarabine is used for lymphodepletion.

Treatment Group

Cyclophosphamide DRUG

Cyclophosphamide is used for lymphodepletion.

Treatment Group

Olverembatinib DRUG

a third-generation TKI

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
• Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
• Organ function as indicated by the following laboratory indicators must be met:
• \. Alanine aminotransferase (ALT) ≤ 5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 5×ULN; 2. Total bilirubin\<2×ULN; 3. 24-hour calculated creatinine clearance\>30 mL/min; 4. SpO2≥92%; 5. Cardiac ejection fraction (EF)≥40%;

You may not qualify if:

• Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA \< 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ;
• Uncontrolled active infection;
• Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS;
• Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg);
• Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension;
• Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL;
• Patients who have any other malignant tumors that require treatment;
• Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L);
• Patients who are pregnant, planning to become pregnant or breastfeeding;
• Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug;
• Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures;
• Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Fundamenta Therapeutics, Ltd.: collaborator

Study Sites (2)

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

Suzhou, Jiangsu, 215000, China

Location

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

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Interventions

fludarabine; Cyclophosphamide; olverembatinib

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: July 20, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (2)