Allogeneic WTX-212C in Advanced Solid Tumors

Summary

This is a multicenter, open-label, single-arm Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of allogeneic WTX-212C, an investigational allogeneic engineered red blood cell (RBC)-based product, in patients with advanced solid tumors who have failed standard therapies or have no available standard treatment options. The study consists of a dose-escalation phase using a 3+3 design followed by a dose-expansion phase. Participants will receive allogeneic WTX-212C via intravenous infusion. Tumor assessments will be performed every 6 weeks according to RECIST 1.1.

Eligibility

Inclusion Criteria:

* Age 18-75 years
* Histologically or cytologically confirmed advanced solid tumors
* At least one measurable lesion per RECIST 1.1
* ECOG performance status ≤1
* Adequate organ function
* Life expectancy ≥12 weeks

Exclusion Criteria:

* Uncontrolled serious medical conditions
* Active or uncontrolled infections
* Symptomatic or unstable CNS metastases
* History of severe hypersensitivity to biologic agents
* Autoimmune diseases requiring systemic treatment
* Prior severe immune-related adverse events
* Conditions affecting red blood cell integrity

Conditions2

Interventions1

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