Recruiting
Phase 2

Obecabtagene Autoleucel

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07400029

Conditions

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Obecabtagene Autoleucel

Study Details

Brief summary:

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).

Conditions

Acute Lymphoblastic Leukemia

Study ID

NCT07400029

Start date

Feb 3, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of CD19+ B-cell ALL.

  • Both Ph-negative and Ph-positive are allowed
  • Patients with EMD must have detectable disease in the bone marrow (by flow cytometry or molecular methods) in order to follow MRD.
  • Patients aged ≥ 40 years at time of screening A.
  • Patients aged 30-39 years (at time of Screening A) are allowed in the presence of high-risk comorbidities or poor tolerability of chemotherapy (e.g. history or experienced pancreatitis with therapy, BMI ≥40kg/m2, underlying liver disease precluding safer administration of pediatric inspired regimens, any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric or pediatric-inspired standard chemotherapy regimen).
  • In MRD negative CR or CR with incomplete hematologic recovery (CRi) at the time of screening. MRD will be assessed by flow cytometry and/or molecular testing such as ClonoSEQ at the minimum sensitivity of 10-4 from the bone marrow. Patients with MRD <10\^-4 will be eligible.
  • Patients may receive more than one course of upfront induction and/or consolidation, but must be in MRD- CR/CRi at time of screening, within 4 months from initiation of treatment. The 4-month window will be measured from the first day of anti-leukemic therapy initiation (excluding steroid prophase) until the Screening A test for the trial.

Frontline regimens include but are not limited to:

  • HyperCVAD or mini-hyper-CVD
  • Asparaginase-containing multiagent chemotherapy (e.g. CALGB10403, pediatric inspired chemo)
  • Inotuzumab or blinatumomab with or without chemotherapy
  • Tyrosine kinase inhibitor plus steroids, chemotherapy, or blinatumomab

\- Adequate organ function at time of screening A, including:
  • ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)
  • Serum creatinine <2.0mg/dL
  • SaO2 ≥92% on room air
  • Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening

  • ECOG performance status 0-2
  • CD19 expression is required at any time since diagnosis. CD19 expression may be detected by immunohistochemistry or by flow cytometry. Patients receiving prior blinatumomab are eligible if there is no documentation of CD19-negative disease after blinatumomab.
  • CNS1 status must be documented at time of screening by CSF assessment. Patients with prior CNS2 or CNS3 disease must be CNS1 at screening and have no residual CNS deficits or symptoms.
  • Patients will need to adhere to institutional contraception guidelines for a minimum of 1 year.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion Criteria:

  • Burkitt's leukemia or lymphoma
  • Patients with measurable extramedullary disease at screening are excluded. Patients with prior history of extramedullary disease are allowed after documentation of disease resolution by either PET/CT scan (or CT with contrast if PET cannot be performed).
  • The following medications are excluded:

  • Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.
  • Systemic chemotherapy: Must be discontinued 7 days prior to leukapheresis or 7 days prior to starting lymphodepleting chemotherapy if used during bridging.
  • Tyrosine kinase inhibitors: Must be discontinued 48 hours prior to apheresis and 48 hours prior to starting lymphodepleting chemotherapy, if used during bridging.
  • Blinatumomab must be discontinued 5 days before apheresis
  • Inotuzumab must be discontinued 2 weeks before apheresis to allow T cell recovery
  • Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion
  • Blinatumomab may not be used as bridging therapy following apheresis
  • Positive test indicating the presence of active infection with the following pathogens: HIV, Hepatitis B (detectable Hep B DNA by PCR or Hep B surface antigen), Hepatitis C (detectable Hep C RNA by PCR), HTLV, Syphilis. The tests required will be agreed upon with the manufacturer to comply with manufacturer's regulatory and manufacturing requirements.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A

will enroll Philadelphia chromosome negative patients

experimental: Cohort B

is an exploratory cohort that will enroll Philadelphia chromosome positive patients

Interventions

Obecabtagene Autoleucel

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ioannis Kalogirou Valtis, MD

646-608-2091kalogii@mskcc.org

Mark Geyer, MD

646-608-3745

Locations

City of Hope Cancer Center (Data collection AND Specimen Analysis)

Recruiting

Duarte, California, United States, 91010

Contacts

Ibrahim Aldoss, MD

877-814-1610

Stanford University (Data Collection AND Specimen Analysis)

Recruiting

Stanford, California, United States, 94305

Contacts

Lori Muffly, MD

650-498-6000

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Ioannis Kalogirou Valtis, MD

646-608-2091

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Ioannis Kalogirou Valtis, MD

646-608-2091

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Ioannis Kalogirou Valtis, MD

646-608-2091

Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Ioannis Kalogirou Valtis, MD

646-608-2091

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Ioannis Kalogirou Valtis, MD

646-608-2091

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Ioannis Kalogirou Valtis, MD

646-608-2091

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Ioannis Kalogirou Valtis, MD

646-608-2091

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Obecabtagene Autoleucel
  • B-cell
  • 25-342

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-20.