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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Participants of age ≥18 years with documented relapsed or refractory B-cell ALL

KMT2A rearranged ALL

Complex cytogenetics as per NCCN 2022

Low-hypodiploidy/tetraploidy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Blinatumomab
  • Inotuzumab Ozogamicin
  • Hyper-CVAD
  • Mini-hyper-CVD

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators