New CAR T-Cell therapy aims to stop High-Risk leukemia from returning
NCT ID NCT07053059
First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This Phase 2 trial is testing whether a CAR T-cell therapy called obecabtagene autoleucel (obe-cel) can help control newly diagnosed, high-risk B-cell acute lymphoblastic leukemia (ALL) after initial treatment. The study will enroll 30 adults with high-risk features who are in first remission. Researchers will monitor safety and side effects to see if this approach improves outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- obecabtagene autoleucel (obe-cel), a type of CAR T-cell therapy
- What this could lead to
- If successful, this could offer a more effective way to control high-risk B-cell ALL after initial treatment, potentially reducing the chance of relapse.
- What could go wrong
- This is an early Phase 2 trial with only 30 participants, so results may not apply to all patients. CAR T-cell therapy can cause serious side effects like cytokine release syndrome or neurological problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: I. Patients of age .18 years with high-risk B-cell ALL in first remission and \<5% BM blasts with at least one high-risk feature defined as: 1. Ph-negative B-cell ALL: 1. KMT2A rearranged ALL 2. Complex cytogenetics as per NCCN 2022 3. Low-hypodiploidy/tetraploidy 4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions) 5. TP53 mutation (variant allele fraction \>2%) 6. Persistent MRD by flow cytometry and/or NGS 2. Ph-positive B-cell ALL: 1. IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc. 2. High WBC (\>30 x 109/L) at initial presentation 3. Persistent MRD by flow cytometry and/or NGS and/or PCR II. Performance status of 0, 1, or 2 III. 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 IV. Patients should be CD19 expression positive (\>1%) before enrollment V. Patients with controlled CNS and/or other extramedullary leukemia will be eligible. Exclusion Criteria: 1. 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. 2. Patients with history of Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) infections, even if under control. (Patients with Hepatitis B core antibody positive alone will not be an exclusion factor if HBV DNA PCR is negative). 3. Active and uncontrolled disease/infection as judged by the treating physician 4. Unable or unwilling to sign the consent form
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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