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

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed/Refractory, B-cell Acute Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT06287229

Run by

M.D. Anderson Cancer Center

People needed

40

Starts

2024-07-11

Expected to finish

2030-12-31

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.