A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07400029
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Obecabtagene Autoleucel — DRUG
    Given as infusion. Obe-cel dose 1: Obe-cel will be administered 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy, allowing a minimum of 48 hour washout from the last dose of lymphodepleting chemotherapy.

Study Details

The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).

Key Dates

Start date
Feb 3, 2026
Status verified
May 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    will enroll Philadelphia chromosome negative patients
  • Experimental: Cohort B
    is an exploratory cohort that will enroll Philadelphia chromosome positive patients

Primary Outcome Measure

relapse free survival (RFS) (Cohort A) [ Time Frame: 1 year from infusion ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Ioannis Kalogirou Valtis, MD
646-608-2091
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Ioannis Kalogirou Valtis, MD
646-608-2091
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Ioannis Kalogirou Valtis, MD
646-608-2091
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)CommackNew York11725
Ioannis Kalogirou Valtis, MD
646-608-2091
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Ioannis Kalogirou Valtis, MD
646-608-2091
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Ioannis Kalogirou Valtis, MD
646-608-2091
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Ioannis Kalogirou Valtis, MD
646-608-2091

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