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

NCT05993949 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB-68603NCI-2023-05591
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoblastic Leukemia

Keywords

Leukemia; CAR T cell therapy; Brexucabtagene Autoleucel; Dasatinib

Outcome Measures

Primary Outcomes (1)

• Feasibility of dasatinib pulses

  Feasibility of administering oral dasatinib pulses (3 consecutive doses per week) during the first month following Tecartus infusion. Feasibility will be defined as the ability of 8 out of 20 subjects to miss no more than one cycle (defined as one week of at least three consecutive days of dasatinib) within the first month following Tecartus infusion.

  1 month

Secondary Outcomes (7)

• Safety of oral dasatinib pulses

  2 years

• Overall response rate

  3 months

• Complete Response (CR)

  3 months

• MRD-negative Complete Response (CR)

  3 months

• Duration of CR in responders

  2 years

Study Arms (1)

Dasatinib

EXPERIMENTAL

Oral dasatinib 100mg

Drug: Dasatinib

Interventions

Dasatinib DRUG

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

Dasatinib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Kite, A Gilead Company: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Lori Muffly, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 15, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)