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Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2020-133
NCT ID
NCT04771078
Age Group
Adult
Scope
National
Phase
Phase II
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase II
Principal Investigator
Abhinav
Deol, M.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objective: The primary objective of the study is to assess the safety of nonconforming ide-cel.
Secondary Objective: The secondary objective of the study is to assess the efficacy of nonconforming ide-cel.
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NCI Dictionary of Cancer Terms
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
Clinically stable
Exclusion Criteria:
Has a hypersensitivity to the active substance or to any of the excipients
No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Multiple Myeloma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
CAR-T, Cellular Therapy
Drugs
BB2121
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