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New treatment option for Acute Lymphoblastic Leukemia
Official title A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07400029
What this study is testing
What is Obecabtagene Autoleucel?
Obecabtagene Autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as Obe-cel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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 side effects of chemotherapy (e.g...
You likely can't join if
- Burkitt's leukemia or lymphoma
- Patients with measurable extramedullary disease at screening are excluded. Patients with prior history of extramedullary disease are allowed after...
- 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...
- Systemic chemotherapy: Must be discontinued 7 days prior to leukapheresis or 7 days prior to starting lymphodepleting chemotherapy if used during...
- Tyrosine kinase inhibitors: Must be discontinued 48 hours prior to apheresis and 48 hours prior to starting lymphodepleting chemotherapy, if used...
See the full eligibility 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 side effects of chemotherapy (e.g. history or experienced pancreatitis with therapy, BMI ≥40kg/m2...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.