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Taking people in United StatesPhase 2

Tests obecabtagene autoleucel as consolidation for newly diagnosed high-risk B-cell leukemia

Tests obecabtagene autoleucel after first-phase treatment in adults with newly diagnosed high-risk B-cell leukemia.

Key facts

Who runs it
M.D. Anderson Cancer Center
Where
Houston, United StatesSee the site
Trial code
Registry 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)
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
26 Aug 2025
Expected to end
31 May 2030
Type of study
Interventional
Treatments tested
  • Obecabtagene autoleucel
Record updated
12 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed B-cell acute lymphocytic leukemia (ALL) at high risk, in first remission. They would get obecabtagene autoleucel after first-phase treatment.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
High-risk B-cell ALL in first remission, with less than 5% blasts in the bone marrow and at least one high-risk feature. Features depend on Ph-negative or Ph-positive ALL (for example KMT2A rearrangement, TP53 mutation, persistent MRD, high white cell count). Leukemia in the brain or spinal cord or elsewhere outside the marrow can join if it is controlled.
Earlier treatment
The record says the leukemia must be in first remission after first-phase treatment. It names no other required or banned prior treatment.
Biomarker or test result
Leukemia cells must be CD19 positive (more than 1%) before joining. Performance status of 0, 1 or 2 is also needed.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Past hepatitis B, hepatitis C or HIV infection, even if controlled
  • Active infection or disease that is not controlled
  • Unable or unwilling to sign the consent form
  • Organ function outside the limits (creatinine over 1.6 mg/dl (141 µmol/L), bilirubin over 3.5 mg, ALT and AST over 5 times the upper limit of normal)

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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:
  • Ph-negative B-cell ALL:; KMT2A rearranged ALL; Complex cytogenetics as per NCCN 2022; Low-hypodiploidy/tetraploidy; Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions); TP53 mutation (variant allele fraction >2%); Persistent MRD by flow cytometry and/or NGS
  • Ph-positive B-cell ALL:; IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc; High WBC (>30 x 109/L) at initial presentation; 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

Who cannot take part

  • 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
  • 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)
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Unable or unwilling to sign the consent form

Where in United States

  • The University of Texas M. D. Anderson Cancer CenterHouston, United StatesContact: Elias Jabbour, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Treatment with Obecabtagene AutoleucelTreatment being tested

    Participants in morphological remission will be eligible in the present study, the dose of obe-cel will be as per the FELIX trial as follows:

    Treatment: Obecabtagene autoleucel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests obecabtagene autoleucel as consolidation for newly diagnosed high-risk B-cell leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 August 2026