This clinical trial is for adults who have relapsed/refractory acute lymphoblastic leukemia (ALL) and the Obe-Cel product prescribed by their study doctor did not meet commercial release criteria.

The purpose of this Out-Of-Specification (OOS) Obecabtagene-Autoleucel (Obe-Cel) Early Access Program (EAP) is to make Obe-Cel OOS available for adult patients with relapsed or refractory B-cell ALL who have had leukapheresis. This program will also gather real-world safety data to check how safe the experimental intervention with Obe-Cel OOS is.

Manufacturing CAR T therapy products such as Obe-Cel is complex due to the individualized nature of this therapy. The product is manufactured from a participant’s own cells. There are strict specifications set on these products to ensure consistency, safety, and effectiveness for commercial release. However, if any one of the specification criteria is not met, the product is deemed Out-Of-Specification (OOS).

The Obe-Cel product prescribed by the participant’s study doctor was intended for commercial release (meaning it was anticipated that it would be approved for their treatment), however, the product did not meet specific criteria set by the U.S. Food and Drug Administration (FDA). Through this study, the agent can be given to a participant as an investigational product. An “investigational product” in this case means that the product is not approved by the FDA.
   
The main procedures in the study include:
   --A short course (4 days) of pre-conditioning chemotherapy (known as lymphodepletion). Lymphodepletion is a procedure to temporarily kill existing T-cells, removing competition for growth factors and preventing host rejection, allowing infused therapeutic cells to expand, persist, and effectively target tumors.
   --1 or 2 infusions of OOS Obe-Cel will be given into a vein over a few minutes (up to 30 minutes per bag).
   --Following OOS Obe-Cel infusion, participants may need to stay in the hospital (or ambulatory setting) for 10 days or longer so the study doctor can monitor their health and any side-effects from the product and treat as needed.

Participation is expected to last about 52 days.