Actively Recruiting
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)
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Autolus, Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older with high-risk B-cell ALL in first remission and less than 5% bone marrow blasts
- For Ph-negative B-cell ALL, presence of at least one high-risk feature such as KMT2A rearrangement, complex cytogenetics (NCCN 2022), low-hypodiploidy/tetraploidy, Philadelphia-like ALL, TP53 mutation (variant allele fraction >2%), or persistent MRD by flow cytometry and/or NGS
- For Ph-positive B-cell ALL, presence of IKZF1plus genotype or other high-risk features like VPRB1 deletion, high white blood cell count (>30 x 10^9/L) at diagnosis, or persistent MRD by flow cytometry, NGS, or PCR
- Performance status of 0, 1, or 2
- Adequate organ function with creatinine ≤1.6 mg/dL, bilirubin ≤3.5 mg/dL, and ALT/AST ≤5 times institutional upper limit of normal
- Positive CD19 expression (>1%) before enrollment
- Controlled central nervous system and/or other extramedullary leukemia
You will not qualify if you...
- Pregnant or lactating women; women of child-bearing potential must have a negative pregnancy test
- History of Hepatitis B, Hepatitis C, or HIV infections, even if controlled (except Hepatitis B core antibody positive with negative HBV DNA PCR)
- Active and uncontrolled disease or infection as judged by the treating physician
- Unable or unwilling to sign the consent form
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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