Clinical Trial 24192

• Overview

  Study Title:

  An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release

  Summary:

  This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Serious adverse events (SAEs) occurring during the safety reporting period (defined as the day the recipient receives the Orca-T HSPC drug product through day +365 after transplantation or until initiation of new anticancer therapy, whichever occurs sooner) will be reported.

  Objective:

  Its objective is to provide access to Orca-T for eligible patients whose Orca-T products do not meet commercial release criteria. Such products will only be administered if the final manufactured products are deemed safe and acceptable for release after a risk/benefit assessment by the sponsor and treating physician. The treating physician will ultimately determine whether to administer the product. No formal endpoints are associated with this protocol.

• Treatments

  Therapies:

  Cell Therapy

  Medications:

  ORCA-T ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Commercial Orca-T was prescribed to the patient by their treating physician.
  • The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry.
  • The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria.
  • Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.
  • Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Recipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.