Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia

Trial Title: Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia

NCT ID: NCT05993949

Condition: Lymphoblastic Leukemia

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Dasatinib

Conditions: Keywords:
Leukemia
CAR T cell therapy
Brexucabtagene Autoleucel
Dasatinib

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Dasatinib
Description: 3 pulses of oral dasatinib (100 mg daily) beginning on Day 4 (+up to 2 days) for 3 days (with 4 days off), repeated weekly. The weekly 3-day pulse schedule of dasatinib may continue for up to 3 months in subjects who continue to meet the dasatinib eligibility criteria and who do not meet off treatment/off study criteria
Arm group label: Dasatinib

Summary: To assess the feasibility of oral dasatinib pulses (3 consecutive days per week) during the first month following infusion of brexucabtagene autoleucel (Tecartus) in adults with relapsed or refractory B-cell acute lymphoblastic leukemia.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Relapsed or refractory B-precursor ALL defined as one of the following: - Primary refractory disease (>=5% blasts or persistent extramedullary disease following induction therapy) - First or later relapse of marrow or extramedullary disease - Persistence of MRD defined as detectable ALL by flow cytometry, PCR, or next-generation sequencing - Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from transplant at time of enrollment - Patients with isolated, asymptomatic CNS relapse will be eligible - Age >=18 years - Eastern cooperative oncology group (ECOG) performance status of 0-2 - Adequate renal, hepatic, pulmonary and cardiac function defined as: - Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome. - Cardiac ejection fraction ≥ 50%, no evidence of clinically significant pericardial effusion, and no clinically significant arrhythmias - Baseline oxygen saturation > 92% on room air - QTc ≤ 500ms - In individuals previously treated with blinatumomab, CD19 tumor expression in bone marrow or peripheral blood by flow cytometry or extramedullary site by IHC or flow cytometry - Negative serum or urine beta-HCG test in females of childbearing potential within 3 weeks of enrollment - Subjects of childbearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study Page 10 of 83 Version 1.0 dated 27-April-2023 and for six (6) months after receiving the preparative conditioning regimen. - Must be able to give informed consent. Legal authorized representative (LAR) is permitted if subject is cognitively able to provide verbal assent. Exclusion Criteria: - History of dasatinib intolerance - Known sensitivity or allergy to aminoglycosides or any agents/reagents used in this study - Blast count > 75% in the bone marrow. - History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years - Presence of CNS-3 disease with neurological changes - History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage with clinical signs or symptoms - History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond or any known bone marrow failure syndrome - History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment - Primary immunodeficiency - Known infection with HIV, hepatitis B (HBsAg positive) or untreated hepatitis C virus - Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. - Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment - Pregnant or breast feeding - Patients with known autoimmune disease requiring the use of systemic immunosuppressive therapy within the last year - Corticosteroid therapy within 7 days prior to enrollment - Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment - Live vaccine ≤ 4 weeks prior to enrollment - Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Stanford University

Address:
City: Palo Alto
Zip: 94305
Country: United States

Status: Recruiting

Contact:
Last name: Lindsay Danley

Phone: 650-736-0304
Email: lindsmd@stanford.edu

Start date: October 2, 2023

Completion date: August 2025

Lead sponsor:
Agency: Stanford University
Agency class: Other

Collaborator:
Agency: Kite Pharma
Agency class: Other

Source: Stanford University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05993949