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  • A Phase 1/2 Study of YH001 in Combination With Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or intolerant to other available therapies.

  • Expanded Access Protocol for Product which does not conform to the TECELRA® (afamitresgene autoleucel, suspension for intravenous infusion) Commercial Release Specification Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this expanded access protocol (EAP) is to provide controlled access to afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers (ATCs) where TECELRA is being administered and where the EAP is approved to be conducted. Nonconforming (NC), or out of specification (OOS), for this protocol is defined as at least one batch release test not meeting the registered commercial release specification for TECELRA.

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