Advanced Solid TumorsEarly Phase 1WTX-212C-IITNCT07556653
Allogeneic WTX-212C in Advanced Solid Tumors
A Early Phase 1 study testing allogeneic WTX-212C in people with Advanced Solid Tumors, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- allogeneic WTX-212C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2026to 9 Apr 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial Hospital
Hangzhou, Zhejiang
Yang Liu, PhD, 8613666601475, Yangliuqq2003@163.com
About this study
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
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- allogeneic WTX-212C
- Keywords
- Engineered Red Blood Cells, Immunotherapy, Phase I, Solid Tumor, Allogeneic Engineered Red Blood Cell, uRBC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic WTX-212CDrug
allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Allogeneic WTX-212C | Experimental | Participants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts. Receives: Drug: allogeneic WTX-212C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: Within 21 days after the first dose
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: Up to 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start26 Jun 2026
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake Therapeutics, First People's Hospital of Hangzhou
- Responsible party
- Principal investigator, Liu Yang, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556653
- Sponsor's protocol ID
- WTX-212C-uRBC-IIT-001CN
- Acronym
- WTX-212C-IIT
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07556653
- Acronym / sponsor ID
- WTX-212C-IIT / WTX-212C-uRBC-IIT-001CN
- Conditions
- Advanced Solid Tumors
- Keywords
- Engineered Red Blood Cells, Immunotherapy, Phase I, Solid Tumor, Allogeneic Engineered Red Blood Cell, uRBC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Westlake Therapeutics, First People's Hospital of Hangzhou
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Allogeneic WTX-212C | Experimental | Drug: allogeneic WTX-212CParticipants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic WTX-212Callogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously. | Drug | Experimental: Allogeneic WTX-212C |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Within 21 days after the first dose
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Time frame: Up to 12 months
Incidence of Dose-Limiting Toxicities (DLTs)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing allogeneic WTX-212C in people with Advanced Solid Tumors, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu, PhD (8613666601475, Yangliuqq2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Within 21 days after the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.