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Lymphoblastic LeukemiaPhase 1NCT05993949

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

A Phase 1 study testing Dasatinib in people with Lymphoblastic Leukemia, run by Stanford University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoblastic Leukemia
What is being tested?
Dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
2 Oct 2023to Jun 2040
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Palo Alto, California, 94305

Other trials in United States

About this study

Official title: Phase 1b Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia

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.

Being tested
Dasatinib
Keywords
Leukemia, CAR T cell therapy, Brexucabtagene Autoleucel, Dasatinib
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    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

Study groups in NCT05993949
Study groupRoleWhat they receive
DasatinibExperimentalOral dasatinib 100mg
Receives: Drug: Dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month

Secondary outcomes (7)

  1. Safety of oral dasatinib pulses

    Defined by a description of adverse events and serious adverse events at least possibly related to dasatinib following CAR T cell therapy; it will include an analysis of the sequential toxicity boundaries in that the analysis does not lead to a pause in the study; further defined as no reports of suspected death on study.

    Measured: 2 years

  2. Overall response rate

    The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2).

    Measured: 3 months

  3. Complete Response (CR)

    The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2).

    Measured: 3 months

  4. MRD-negative Complete Response (CR)

    The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2).

    Measured: 3 months

  5. Duration of CR in responders

    Measured: 2 years

  6. Progression Free Survival (PFS) following Tecartus plus dasatinib

    PFS is defined as the time from the start of the investigational therapy to the date of radiographic progression

    Measured: 2 years

  7. Overall Survival (OS) following Tecartus plus dasatinib

    OS is defined as the time from the date of initial disease diagnosis to the date of death from any cause

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start2 Oct 2023
  3. Primary completion17 Jul 2025
  4. Study completionJun 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993949
Sponsor's protocol ID
IRB-68603
Other IDs
NCI-2023-05591
Status last verified
Oct 2026
First submitted
10 Jul 2023
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dasatinib in people with Lymphoblastic Leukemia, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of dasatinib pulses (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05993949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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