Allogeneic WTX-212C in Advanced Solid Tumors
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
Run by Zhejiang Provincial People's Hospital · NCT07556653 · Data updated 2026-11-12
This early-phase study tests whether an allogeneic engineered red blood cell product, WTX-212C, is safe and may help people with advanced solid tumors who have few or no good treatment options.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | June 26, 2026 |
| Main results expected | April 9, 2027 |
| Study ends | April 9, 2028 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07556653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with histologically or cytologically confirmed advanced solid tumors, at least one measurable lesion, ECOG 0-1, and adequate organ function who have exhausted standard therapies or have no satisfactory options.
✕Probably not a fit
Patients with uncontrolled medical conditions, active infections, CNS metastases requiring symptoms control, or prior severe immune-related events may not benefit and could be excluded due to safety concerns.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label, single-arm Phase I trial evaluates safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of WTX-212C given by IV infusion in adults with advanced solid tumors that have failed standard therapies. The study uses a traditional 3+3 dose-escalation design to identify a safe dose, followed by a dose-expansion to further assess safety and early efficacy at selected dose levels. Exploratory analyses will include immune profiling and biomarker assessments such as PD-1/PD-L1, tumor mutational burden, and MSI status. Tumor responses are monitored every 6 weeks using RECIST 1.1 criteria.
Why it matters
Potential benefit: If successful, participants might experience disease stabilization or tumor shrinkage and gain more time with an acceptable safety profile.
How similar studies have gone: Prior studies of engineered cell–based therapies in solid tumors show early signals of activity in some settings, but this approach with allogeneic engineered RBCs is exploratory and has not yet demonstrated definitive efficacy.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Zhejiang Provincial Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Yang Liu, PhD
- Email: Yangliuqq2003@163.com
- Phone: 8613666601475
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.