An Early Phase 1 interventional study of allogeneic WTX-212C in Advanced Solid Tumors, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Zhejiang Provincial People's Hospital · Early Phase 1, Interventional, and Treatment
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.
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.
Zhejiang Provincial People's Hospital is the lead sponsor of 62 studies on the registry; 42 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts.
Drug: allogeneic WTX-212C
allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Within 21 days after the first dose
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Up to 12 months
Maximum Tolerated Dose (MTD)
MTD is defined as the highest dose level at which no more than 1 out of 6 participants experiences a dose-limiting toxicity (DLT) during the first treatment cycle, based on a standard 3+3 dose-escalation design.
Time frame: Within 21 days after the first dose
Pharmacokinetic Parameters (Cmax)
Plasma pharmacokinetic parameters of allogeneic WTX-212C, including maximum observed concentration (Cmax）will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria, based on investigator assessment.
Time frame: Up to 12 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1 criteria.
Time frame: Up to 12 months
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of allogeneic WTX-212C to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame: Up to 12 months
Incidence of Anti-Drug Antibodies (ADA)
The incidence of anti-drug antibodies (ADA) against allogeneic WTX-212C will be assessed using validated immunoassays.
Time frame: From baseline up to 12 months
Pharmacokinetic Parameters (AUC)
Plasma pharmacokinetic parameters of allogeneic WTX-212C，area under the concentration-time curve (AUC), will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
Pharmacokinetic Parameters (Tmax)
Plasma pharmacokinetic parameters of allogeneic WTX-212C, time to maximum concentration (Tmax) will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
Pharmacokinetic Parameters (T1/2)
Plasma pharmacokinetic parameters of allogeneic WTX-212C, and terminal elimination half-life (t1/2) will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
Changes in Immune Cell Subsets in Peripheral Blood
Quantitative and phenotypic analysis of peripheral blood immune cell subsets (e.g., T cells, B cells, NK cells) will be performed using flow cytometry to assess immunological changes following treatment.
Time frame: From baseline up to 12 months
Exposure-Response Relationship
The relationship between pharmacokinetic exposure parameters (e.g., Cmax, AUC) and clinical outcomes (safety and efficacy endpoints) will be explored using descriptive and model-based analyses.
Time frame: Up to 12 months
Plan to share: Undecided
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Zhejiang Provincial People's Hospital