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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06287229 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD19 CAR T cell therapy, investigational therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Are patients with BCR alterations eligible?
No. BCR fusion is an exclusion criterion.
Are patients with ABL1 alterations eligible?
No. ABL1 fusion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages