RecruitingPhase 2

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

A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether obecabtagene autoleucel (obe-cel) works for people with B-cell acute lymphoblastic leukemia (ALL). It is for people who have had treatment and are in their first remission with no detectable cancer cells.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have B-cell ALL with a protein called CD19 on the cancer cells.
  • Be age 40 or older, or age 30–39 with serious health problems or trouble handling chemotherapy.
  • Be in remission with no detectable cancer cells on sensitive bone marrow tests. Blood cell counts may still be low.
  • Reach this remission and have the study screening test within 4 months of starting leukemia treatment.
  • Have liver, kidney, lung, and heart test results that meet the study’s limits.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Have no leukemia found in the fluid around the brain and spinal cord at screening. If leukemia was there before, have no lasting symptoms from it.
  • Follow the study center’s birth control rules for at least 1 year.

Who can't join

  • Have Burkitt’s leukemia or lymphoma.
  • Have measurable leukemia outside the bone marrow at screening. If you had it before, scans must show it is gone.
  • Use certain medicines too close to cell collection or study treatment. Steroids, chemotherapy, and some targeted drugs must be stopped for set times.
  • Have an uncontrolled infection when cells are collected or when the CAR T-cell treatment is given.
  • Use blinatumomab as treatment between cell collection and CAR T-cell treatment.
  • Have a positive test showing active HIV, hepatitis B, hepatitis C, HTLV, or syphilis infection.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (9)

CA

NJ

NY