Acute Lymphoblastic LeukemiaPhase 2NCT07400029
A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia
A Phase 2 study testing Obecabtagene Autoleucel in people with Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Obecabtagene Autoleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Feb 2026to Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mark Geyer, MD contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Ioannis Kalogirou Valtis, MD, 646-608-2091
- Recruiting
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)
Commack, New York, 11725
Ioannis Kalogirou Valtis, MD, 646-608-2091
- Recruiting
City of Hope Cancer Center (Data collection AND Specimen Analysis)
Duarte, California, 91010
Ibrahim Aldoss, MD, 877-814-1610
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Ioannis Kalogirou Valtis, MD, 646-608-2091
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Ioannis Kalogirou Valtis, MD, 646-608-2091
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Ioannis Kalogirou Valtis, MD, 646-608-2091
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Ioannis Kalogirou Valtis, MD, 646-608-2091
- Recruiting
Stanford University (Data Collection AND Specimen Analysis)
Stanford, California, 94305
Lori Muffly, MD, 650-498-6000
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Ioannis Kalogirou Valtis, MD, 646-608-2091
About this study
Official title: A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease
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
- Being tested
- Obecabtagene Autoleucel
- Keywords
- Obecabtagene Autoleucel, B-cell, 25-342
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obecabtagene AutoleucelDrug
Also called Obe-cel
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 group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | will enroll Philadelphia chromosome negative patients Receives: Drug: Obecabtagene Autoleucel |
| Cohort B | Experimental | is an exploratory cohort that will enroll Philadelphia chromosome positive patients Receives: Drug: Obecabtagene Autoleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse free survival (RFS) (Cohort A)
The time from CAR T infusion until non-response, relapse, or death of any cause, censored at last follow up. Non-response will be defined as the presence of > 5% abnormal lymphoblasts in the bone marrow, or the presence of unequivocal CNS or extramedullary disease after obe-cel infusion. Relapse will be defined as the emergence of > 5% abnormal lymphoblasts in the bone marrow, or the emergence of new unequivocal CNS or extramedullary disease after obe-cel infusion. Patients will be censored for relapse free survival if they undergo allogenic stem cell transplant or receive any other new treatment (except start or change of TKI maintenance) while in remission.
Measured: 1 year from infusion
Secondary outcomes (1)
Minimal residual disease (MRD)-negative Event Free Survival (EFS) (Cohort A & B)
The time from CAR T infusion until non-response (including MRD), relapse (including MRD), or death of any cause, censored at last follow up. MRD will be measured in the bone marrow as described above and considered positive if >10-^4.
Measured: 1 year from infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start3 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Autolus Limited
- Responsible party
- Sponsor
- Investigators
- Ioannis Kalogirou Valtis, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400029
- Sponsor's protocol ID
- 25-342
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease
- ClinicalTrials.gov ID
- NCT07400029
- Acronym / sponsor ID
- 25-342
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Obecabtagene Autoleucel, B-cell, 25-342
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Autolus Limited
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Obecabtagene Autoleucelwill enroll Philadelphia chromosome negative patients |
| Cohort B | Experimental | Drug: Obecabtagene Autoleucelis an exploratory cohort that will enroll Philadelphia chromosome positive patients |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosis of CD19+ B-cell ALL.
- 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.
Key exclusion criteria (11 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obecabtagene AutoleucelAlso: Obe-celGiven 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. | Drug | Cohort A, Cohort B |
Primary outcome
relapse free survival (RFS) (Cohort A)
Time frame: 1 year from infusion
The time from CAR T infusion until non-response, relapse, or death of any cause, censored at last follow up. Non-response will be defined as the presence of > 5% abnormal lymphoblasts in the bone marrow, or the presence of unequivocal CNS or extramedullary disease after obe-cel infusion. Relapse will be defined as the emergence of > 5% abnormal lymphoblasts in the bone marrow, or the emergence of new unequivocal CNS or extramedullary disease after obe-cel infusion. Patients will be censored for relapse free survival if they undergo allogenic stem cell transplant or receive any other new treatment (except start or change of TKI maintenance) while in remission.
1 secondary outcome
Minimal residual disease (MRD)-negative Event Free Survival (EFS) (Cohort A & B)
Time frame: 1 year from infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Geyer, MD contact
Ioannis Kalogirou Valtis, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obecabtagene Autoleucel in people with Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ioannis Kalogirou Valtis, MD (646-608-2091, kalogii@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse free survival (RFS) (Cohort A) (time frame: 1 year from infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.