Actively Recruiting
A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-24
40
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Autolus Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CD19 positive B-cell acute lymphoblastic leukemia, including both Ph-negative and Ph-positive types
- Patients with extramedullary disease must have detectable bone marrow disease to monitor MRD
- Age 40 years or older at screening; patients aged 30-39 may participate if they have high-risk health issues or poor chemotherapy tolerance
- In first measurable residual disease negative complete remission (MRD-negative CR) or CR with incomplete blood recovery at screening
- MRD assessed by flow cytometry or molecular tests with sensitivity of at least 10-4 from bone marrow
- Patients may have had multiple induction or consolidation treatments but must be in MRD-negative CR or CRi within 4 months of starting treatment
- Adequate organ function including liver enzymes, bilirubin, kidney function, oxygen saturation, and heart function
- ECOG performance status 0 to 2
- CD19 expression confirmed at any time since diagnosis
- CNS1 status documented at screening with no residual CNS symptoms if prior CNS2 or CNS3 disease
- Willing to follow contraception guidelines for at least one year
You will not qualify if you...
- Active cancer other than non-melanoma skin cancer; prior cancers in remission for less than 2 years excluded
- Burkitt's leukemia or lymphoma
- Measurable extramedullary disease at screening; prior extramedullary disease allowed if resolved and documented by scan
- Use of therapeutic corticosteroids above specified doses within 7 days before leukapheresis or 72 hours before CAR T infusion
- Use of systemic chemotherapy within 7 days before leukapheresis or lymphodepleting chemotherapy
- Use of tyrosine kinase inhibitors within 48 hours before apheresis and lymphodepleting chemotherapy
- Blinatumomab use less than 5 days before apheresis
- Inotuzumab use less than 2 weeks before apheresis
- Uncontrolled systemic infection at time of leukapheresis or CAR T infusion
- Use of blinatumomab as bridging therapy after apheresis
- Positive test for active infection with HIV, Hepatitis B or C, HTLV, or syphilis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
J
Jae Park, MD
CONTACT
M
Mark Geyer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here