Allogeneic WTX-212C in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: allogeneic WTX-212C.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Open-label, Single-arm Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Allogeneic WTX-212C Engineered Red Blood Cell Injection in Patients With Advanced Solid Tumors
Overview
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.
Detailed description
This Phase I study aims to characterize the safety profile, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics, immunogenicity, and preliminary efficacy of allogeneic WTX-212C in patients with advanced solid tumors.
The dose-escalation phase will follow a traditional 3+3 design with predefined dose levels. The dose-expansion phase will further evaluate safety, PK, and antitumor activity at selected dose levels.
Exploratory analyses will include immune profiling, tumor microenvironment assessment, and evaluation of biomarkers such as PD-1/PD-L1 expression, tumor mutational burden (TMB), and microsatellite instability (MSI) status.
Interventions
- Drug allogeneic WTX-212C
allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.
Primary outcome measures
- Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: Within 21 days after the first dose]
- Incidence and Severity of Treatment-Related Adverse Events (TRAEs) [Time frame: Up to 12 months]
Secondary outcome measures (9)
- Maximum Tolerated Dose (MTD) [Time frame: Within 21 days after the first dose]
- Pharmacokinetic Parameters (Cmax) [Time frame: From first dose up to 12 months]
- Objective Response Rate (ORR) [Time frame: Up to 12 months]
- Disease Control Rate (DCR) [Time frame: Up to 12 months]
- Progression-Free Survival (PFS) [Time frame: Up to 12 months]
- Incidence of Anti-Drug Antibodies (ADA) [Time frame: From baseline up to 12 months]
- Pharmacokinetic Parameters (AUC) [Time frame: From first dose up to 12 months]
- Pharmacokinetic Parameters (Tmax) [Time frame: From first dose up to 12 months]
- Pharmacokinetic Parameters (T1/2) [Time frame: From first dose up to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Provincial Hospital — Hangzhou
Identifiers
NCT: NCT07556653 · WTX-212C-uRBC-IIT-001CN