Recruiting
Phase 1
Phase 2

Brexucabtagene Autoleucel

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06287229

Conditions

Relapsed/Refractory

B-cell Acute Lymphocytic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blinatumomab

Inotuzumab Ozogamicin

Hyper-CVAD

Mini-hyper-CVD

Study Details

Brief summary:

To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.

Conditions

Relapsed/Refractory

B-cell Acute Lymphocytic Leukemia

Study ID

NCT06287229

Start date

Jul 11, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants of age ≥18 years with documented relapsed or refractory B-cell ALL
  • In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as:

1. KMT2A rearranged ALL
2. Complex cytogenetics as per NCCN 2022
3. Low-hypodiploidy/tetraploidy
4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
  • Performance status of 0, 1, or 2
  • Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal
  • Participants should be CD19 expression positive (>50%) before enrollment
  • Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I/II will be eligible if they are on therapy and infections are under control.

Exclusion Criteria

  • Philadelphia positive B-cell ALL
  • Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
  • Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Unable or unwilling to sign the consent form
  • No other investigational therapy within the past 14 days

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1B + Phase 2

Participants found to be eligible to take part in this study, you will be assigned to a study phase (Phase 1B or Phase 2). Up to 10 participants will be enrolled in Phase 1B, and up to 30 will be enrolled in Phase 2. All participants will first receive cytoreductive therapy (inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD), followed by lymphodepletion chemotherapy and 1 dose of brexucabtagene autoleucel.

Interventions

Blinatumomab

Given by Infusion

Inotuzumab Ozogamicin

Given by IV

Hyper-CVAD

Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.

Mini-hyper-CVD

Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD

Primary outcome measure

  • Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Elias Jabbour, MD

(713) 792-4764ejabbour@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Elias Jabbour, MD

713-792-4764ejabbour@mdanderson.org

Principal Investigator:

Elias Jabbour, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.