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Recruiting EARLY_Phase 1 NCT05707325

Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies

Trial Parameters

Condition Cancer
Sponsor Westlake Therapeutics
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-01-16
Completion 2025-12-31
Interventions
engineered red blood cell

Brief Summary

This is an investigator-initiated trial aimed at evaluating the safety and preliminary efficacy of a novel red blood cell-based therapy, where engineered red blood cells are conjugated with checkpoint inhibitors.

Eligibility Criteria

Inclusion Criteria: * 1.Histologically- or cytologically-proven advanced malignancies; * 2.Male or female, 18 years of age or older but no more than 75 at the time of signing informed consent; * 3.Dose escalation stage: (1) patients with advanced solid tumors who have received at least 2 regimens, and PDx monotherapy or combination therapy is included in the last regimen ; or patients received 1st regimen or above who cannot tolerate standard therapy but PDx monotherapy or combination therapy should be included in the last regimen.(2)Patients with relapsed and refractory malignant lymphomas (including: classic Hodgkin lymphoma (cHL), primary mediastinal large B-cell lymphoma PMBCL , Extranodal NK/T-cell lymphoma ENKTCL, mycosis fungoides/Sezari syndrome MF/SS) , or patients have no standard therapy, or are unable to receive standard therapy, PDx monotherapy or combination therapy is used in the last regimen.(3)All patients did not receive systemic therapy after disease progression and

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