The purpose of this program is to provide access to obe-cel treatment for adult patientswith ALL who have undergone leukapheresis and had obe-cel manufactured from their bloodcells but the product is deemed OOS (does not meet the specifications to be usedcommercially). The target patients for this study have limited options for treatment andrepeat blood sampling is not feasible. The main aims of this study are (1) to provideadult patients with ALL with access to obe-cel and (2) to describe the safety profile ofobe-cel (including CRS, ICANS, serious infections, secondary cancers, and any sideeffects) within the first 45 days after infusion of OOS obe-cel.This study is a single-arm, open-label, multicenter expanded access program (EAP). Thepatient population included in this EAP will be adult patients diagnosed with recurringor refractory ALL who were prescribed obe-cel as part of their standard of care and areeligible 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, havehad 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 allergicreaction to any drugs or metabolites of similar chemical classes as obe-cel, are apregnant 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.).
Not Provided
Biological: Out-of-specification obecabtagene autoleucel
Out-of-specification (OOS) obecabtagene autoleucel (obe-cel) given as a split-dose
infusion based on tumor burden assessment at lymphodepletion according to the United
States prescribing information.
Other Name: OOS Obe-cel
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.
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope Phoenix
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California San Diego Health (UCSD)
La Jolla, California, United States
Stanford University
Palo Alto, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Orlando Health
Orlando, Florida, United States
Emory
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
NYU-Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
TriStar Centennial Medical Center (SCRI)
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Medical City Dallas
Dallas, Texas, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Washington University School of Medicine
Seattle, Washington, United States
MCW Froedtert
Milwaukee, Wisconsin, United States
Medical Information
855-288-5227
medinfo@autolus.com
Autolus Study Director, Study Director
Autolus Limited