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)

NCT07053059 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0580NCI-2025-04660
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Lymphocytic Leukemia (ALL)

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with Obecabtagene Autoleucel

EXPERIMENTAL

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:

Drug: Obecabtagene autoleucel

Interventions

Obecabtagene autoleucel DRUG

given by Infusion

Treatment with Obecabtagene Autoleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Autolus, Ltd: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elias Jabbour, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias Jabbour, MD

CONTACT

(713) 792-4764; ejabbour@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 8, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-02

Locations

US (1)