OncoMatch/Clinical Trials/NCT06287229
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
Is NCT06287229 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Blinatumomab and Inotuzumab Ozogamicin for relapsed/refractory.
Treatment: Blinatumomab · Inotuzumab Ozogamicin · Hyper-CVAD · Mini-hyper-CVD — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (>50%)
Participants should be CD19 expression positive (>50%) before enrollment
Excluded: BCR fusion
Philadelphia positive B-cell ALL
Excluded: ABL1 fusion
Philadelphia positive B-cell ALL
Allowed: KMT2A (MLL) rearrangement
KMT2A rearranged ALL
Allowed: CRLF2 overexpression
Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-CD19 CAR T cell therapy (brexu-cel)
Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy
Cannot have received: investigational therapy
No other investigational therapy within the past 14 days
Lab requirements
Kidney function
creatinine ≤ 1.6 mg/dl
Liver function
bilirubin ≤ 3.5 mg and ALT and AST ≤ 5 times institutional upper limit of normal
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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