Expanded Access Program for OOS Obe-cel for Adults with Acute Lymphoblastic Leukemia (ALL)

Sponsor: Autolus Limited

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06799221

Provider View

This program offers access to obe-cel treatment for adults with ALL who have limited treatment options. It focuses on patients whose obe-cel product doesn't meet commercial standards but is still safe to use. The study aims to provide treatment and monitor safety within 45 days after infusion.

Patient Parameters

Program Overview

This program is designed to provide obe-cel treatment to adult patients with Acute Lymphoblastic Leukemia (ALL) who have already had their blood cells processed to create obe-cel, but the product doesn't meet commercial standards. These patients have limited treatment options, and taking more blood samples isn't feasible. The main goals are to offer treatment and to monitor the safety of obe-cel, including any side effects, within the first 45 days after receiving the treatment. The study is open to adults with recurring or hard-to-treat ALL who have been prescribed obe-cel as part of their standard care and meet specific criteria.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide informed consent.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of relapsed or refractory B cell ALL.
  • Must have been prescribed commercial obe-cel by their doctor as part of standard care before blood cell collection.
  • The manufactured obe-cel does not meet commercial standards but is acceptable for use.
  • Remanufacturing is not suitable according to the doctor.
  • Must be medically fit and stable to receive obe-cel infusions.
  • Women of childbearing potential must have a negative pregnancy test before treatment and use two forms of contraception during treatment and for 12 months after.
  • Men must use two forms of contraception during treatment and for 12 months after and agree not to donate sperm during this time.

Exclusion Criteria

  • History of severe allergic reactions to drugs similar to obe-cel.
  • Pregnant women.
  • Currently participating in another treatment study.

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