Allogeneic WTX-212C in Advanced Solid Tumors

NCT07556653 | Not Yet Recruiting Early Phase 1

• 1 other identifier: WTX-212C-uRBC-IIT-001CN
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Engineered Red Blood Cells; Immunotherapy; Phase I; Solid Tumor; Allogeneic Engineered Red Blood Cell; uRBC

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLTs)

  Incidence of Dose-Limiting Toxicities (DLTs)

  Within 21 days after the first dose

• Incidence and Severity of Treatment-Related Adverse Events (TRAEs)

  Incidence of Dose-Limiting Toxicities (DLTs)

  Up to 12 months

Secondary Outcomes (9)

• Maximum Tolerated Dose (MTD)

  Within 21 days after the first dose

• Pharmacokinetic Parameters (Cmax)

  From first dose up to 12 months

• Objective Response Rate (ORR)

  Up to 12 months

• Disease Control Rate (DCR)

  Up to 12 months

• Progression-Free Survival (PFS)

  Up to 12 months

Other Outcomes (2)

• Changes in Immune Cell Subsets in Peripheral Blood

  From baseline up to 12 months

• Exposure-Response Relationship

  Up to 12 months

Study Arms (1)

Experimental: Allogeneic WTX-212C

EXPERIMENTAL

Participants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts.

Drug: allogeneic WTX-212C

Interventions

allogeneic WTX-212C DRUG

allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.

Experimental: Allogeneic WTX-212C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead
• Westlake Therapeutics: collaborator
• First People's Hospital of Hangzhou: collaborator

Central Study Contacts

Yang Liu, PhD

CONTACT

8613666601475; Yangliuqq2003@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a sequential assignment study consisting of a dose-escalation phase followed by a dose-expansion phase. The dose-escalation phase will follow a standard 3+3 design with predefined dose levels. Dose escalation decisions will be based on the occurrence of dose-limiting toxicities (DLTs) observed during the first treatment cycle. Upon identification of a tolerable dose level, one or more dose-expansion cohorts may be opened to further characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of allogeneic WTX-212C.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 29, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04