IRB Study Number 25-231
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objectives
To provide adult patients with r/r B-cell ALL with access to OOS obe-cel that is acceptable per joint assessment by Autolus and physician taking into account Autolus' release criteria.
To describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary malignancies, and other adverse events [AEs]) within the first 45 days post-first infusion of OOS obe-cel. Development of secondary malignancy is defined as the development of any new malignancy, occurring after the administration of obe-cel.
Inclusion Criteria
Patient (or legally authorized representative) is willing to provide informed consent.
Patient must be ≥ 18 years of age.
Patient must have a confirmed diagnosis of r/r 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), two methods of contraception comprising one 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 two acceptable methods of contraception are used (one by the patient – usually a barrier method, and one 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.
