Overview
Principal investigator
Eligibility criteria
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.
* 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.
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