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OncoMatch/Clinical Trials/NCT07053059

Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)

Is NCT07053059 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Obecabtagene autoleucel for acute lymphocytic leukemia (all).

Phase 2RecruitingM.D. Anderson Cancer CenterNCT07053059Data as of May 2026

Treatment: Obecabtagene autoleucel — The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: KMT2A (MLL) rearrangement

KMT2A rearranged ALL

Required: TP53 mutation (variant allele fraction >2%)

TP53 mutation (variant allele fraction >2%)

Required: IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions (IKZF1plus genotype)

IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions)

Required: VPRB1 deletion

other high-risk features such as VPRB1 deletion

Required: CD19 overexpression (>1%)

Patients should be CD19 expression positive (>1%) before enrollment

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

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 ≤ 1.6 mg/dl, bilirubin ≤ 3.5 mg and ALT and AST ≤ 5 times institutional upper limit of normal

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The University of Texas M. D. Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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