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)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07053059
Phase
PHASE2
Status
Recruiting

Conditions

  • Acute Lymphocytic Leukemia (ALL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obecabtagene autoleucel — DRUG
    given by Infusion

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Obecabtagene Autoleucel
    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:

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Elias Jabbour, MD
713-792-4764
Elias Jabbour, MD (PRINCIPAL_INVESTIGATOR)

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