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Taking people in United StatesPhase 1/2

Tests brexucabtagene autoleucel after chemotherapy for B-cell acute lymphoblastic leukemia

Tests brexucabtagene autoleucel, a cell therapy, in adults with relapsed or newly diagnosed B-cell leukemia.

Key facts

Who runs it
M.D. Anderson Cancer Center
Where
Houston, United StatesSee the site
Trial code
Registry title
Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab
Status
Recruiting
Phase
Phase 1/2
People taking part
40 people, planned
Started
11 Jul 2024
Expected to end
31 Dec 2030
Type of study
Interventional
Treatments tested
  • Blinatumomab
  • Inotuzumab Ozogamicin
  • Hyper-CVAD
  • Mini-hyper-CVD
Record updated
10 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with B-cell acute lymphocytic leukemia that has come back or did not respond to treatment, or with newly diagnosed high-risk disease. They would receive brexucabtagene autoleucel after other treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
B-cell ALL that has relapsed or not responded to treatment (relapsed/refractory), or newly diagnosed high-risk B-cell ALL (KMT2A rearranged, complex cytogenetics, low-hypodiploidy/tetraploidy, or Philadelphia-like ALL). Performance status 0, 1, or 2.
Earlier treatment
Cannot have had brexu-cel or other anti-CD-19 CAR T cell therapy before. No other investigational therapy within the past 14 days.
Biomarker or test result
CD19 expression positive (>50%) before enrollment.

Main reasons for not taking part

  • Philadelphia positive B-cell ALL
  • Pregnant or breastfeeding
  • Prior brexu-cel or other anti-CD-19 CAR T cell therapy
  • Active and uncontrolled disease or infection
  • Other investigational therapy within the past 14 days

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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:; KMT2A rearranged ALL; Complex cytogenetics as per NCCN 2022; Low-hypodiploidy/tetraploidy; 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

Who cannot take part

  • 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
  • No other investigational therapy within the past 14 days
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Philadelphia positive B-cell ALL
  • Unable or unwilling to sign the consent form

Where in United States

  • MD Anderson Cancer CenterHouston, United StatesContact: Elias Jabbour, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Phase 1B + Phase 2Treatment being tested

    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.

    Treatment: Blinatumomab, Inotuzumab Ozogamicin, Hyper-CVAD, and Mini-hyper-CVD

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab
Plain-language title
Tests brexucabtagene autoleucel after chemotherapy for B-cell acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
10 August 2026