UPCC 34425 Expanded Access Program (EAP) for Obecabtagene-Autoleucel (Obe-Cel) Out-Of-Specification (OOS) in Adult Patients with Acute Lymphoblastic Leukemia
Study on Access to Investigational Treatment for Adult Acute Lymphoblastic Leukemia
Brief description of study
The purpose of this program is to provide access to obe-cel treatment for adult patients with ALL who have undergone leukapheresis and had obe-cel manufactured from their blood cells but the product is deemed OOS (does not meet the specifications to be used commercially). The target patients for this study have limited options for treatment and repeat blood sampling is not feasible. The main aims of this study are (1) to provide adult patients with ALL with access to obe-cel and (2) to describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary cancers, and any side effects) within the first 45 days after infusion of OOS obe-cel.
This study is a single-arm, open-label, multicenter expanded access program (EAP). The patient population included in this EAP will be adult patients diagnosed with recurring or refractory ALL who were prescribed obe-cel as part of their standard of care and are eligible for use under the approved local prescribing information.
To be in the study, patients must provide informed consent, be at least 18 years of age, have a confirmed diagnosis of ALL, be medically fit and stable to receive obe-cel, have had commercial obe-cel prescribed by their treating physician as per standard of care, and for whom remanufacturing is not clinically appropriate.
Patients cannot be in the study if they have a history of severe immediate allergic reaction to any drugs or metabolites of similar chemical classes as obe-cel, are a pregnant woman, or are receiving treatment in another study.
All data will be collected from information routinely recorded in the medical record. There is no formal hypothesis testing. Data will be analyzed descriptively (numbers, percentages and ranges, etc.).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Lymphoblastic Leukemia, Acute, Adult, B Cell ALL
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Patient (or legally authorized representative) is willing to provide informed consent.
- Patient must be 18 years of age or older.
- Patient must have a confirmed diagnosis of relapsed/refractory B cell ALL.
- Commercial obe-cel was indicated to the patient by their treating physician as per standard of care prior to leukapheresis.
- The final manufactured obe-cel does not meet the commercial release specifications.
- The final manufactured obe-cel is acceptable per joint assessment by Autolus and physician taking into account Autolus' release criteria.
- Remanufacturing (i.e., repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.
- Patient deemed medically fit and stable to receive obe-cel infusions per their treating physician's evaluation.
- For females of childbearing potential (defined as < 24 months after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to lymphodepletion therapy and confirmed before receiving the first dose of study treatment.
- For females who are not postmenopausal (< 24 months of amenorrhea) or who are not surgically sterile (absence of ovaries and/or uterus), 2 methods of contraception comprising 1 highly effective method of contraception together with a barrier method must be used during the treatment period and for at least 12 months after the last dose of study treatment. They must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 12 months after receiving the last dose of study drug.
- For males, it must be agreed that 2 acceptable methods of contraception are used (1 by the patient - usually a barrier method, and 1 highly effective method by the patient's partner) during the treatment period and for at least 12 months after the last dose of study treatment and that sperm will not be donated during the treatment period and for at least 12 months after the last dose of study treatment.
Exclusion Criteria:
- History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as obe-cel.
- Pregnant women.
- Active participation in an interventional trial.
The purpose of this study is to provide access to an investigational treatment for adult patients with acute lymphoblastic leukemia (ALL). This study is focused on patients who have already had a procedure called leukapheresis, where blood cells are collected, and have had an investigational treatment made from their cells, but the product does not meet commercial specifications.
Participants in this study will receive the investigational treatment, and researchers will observe its safety profile, including any side effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The study will collect data from routine medical records, and no new procedures or tests will be required for participants.
- Who can participate: Adults aged 18 and older with a confirmed diagnosis of relapsed or refractory B cell acute lymphoblastic leukemia (ALL) can participate.
- Study details: Participants will receive an investigational treatment that has been manufactured from their own blood cells. The study will observe the safety of this treatment by collecting data from participants' medical records.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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