CRC (Colorectal Cancer)Early Phase 1Wondercel-UWD1NCT06653010
Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer
A Early Phase 1 study testing Universal CAR-T cells injection for treating mCRC in people with CRC (Colorectal Cancer) and Metastatic Colorectal Cancer, run by Wondercel Biotech (ShenZhen) at 2 sites in China.
Trial summary
This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (REVO-UWD-01) in the metastatic colorectal cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CRC (Colorectal Cancer), Metastatic Colorectal Cancer
- What is being tested?
- Universal CAR-T cells injection for treating mCRC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 23 Oct 2024to 30 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and ≤75 years old.
- Pathological Diagnosis: Pathologically confirmed metastatic colorectal cancer with radiographically confirmed metastatic lesions (e.g., CT or MRI).
- GCC Expression: Tumor lesions assessed by immunohistochemistry (IHC) showing GCC expression ≥1+ in ≥50% of the area (randomly select at least 5 fields from tumor regions for evaluation; at least 5 unstained slides must be provided for assessment).
- Measurable Lesions: At least one measurable lesion per RECIST 1.1 criteria; measurable lesions should not have received prior radiotherapy or interventional local therapy (lesions in previously irradiated or locally treated fields may be selected as target lesions if confirmed to have progressed).
- Prior Treatment: Participants with advanced colorectal cancer who have progressed or are intolerant after ≥2 lines of standard therapy (with clear documentation).
- ECOG Performance Status: 0 or 1.
Show all 22Show fewer
- Expected Survival: ≥90 days (as assessed by the investigator based on the participant's clinical condition).
- Organ Function:
- Absolute neutrophil count ≥1.5 × 10⁹/L;
- Platelet count ≥80 × 10⁹/L;
- Hemoglobin ≥9 g/dL;
- Liver function:
- Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for Gilbert's syndrome);
- AST and ALT ≤5 × ULN;
- INR <1.3 (INR <3 for participants on anticoagulant therapy);
- Serum creatinine ≤1.5 mg/dL (132.6 μmol/L) or eGFR ≥50 mL/min/1.73 m²;
- Cardiac ejection fraction >50%.
- Bleeding Risk: No active bleeding or bleeding tendency.
- Fertility Requirements:
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use effective contraception during treatment and for 8 weeks after the last dose;
- Male participants must also use effective contraception during treatment and for 8 weeks after the last dose.
- Informed Consent: Participants voluntarily enroll in the study, provide signed informed consent, demonstrate good compliance, and cooperate with follow-up.
Who cannot join
- • Pregnant or breastfeeding women;
- • Received chemotherapy, targeted therapy, monoclonal antibody therapy, or traditional Chinese medicine anti-tumor therapy within 14 days prior to cell collection;
- • Participated in another drug clinical trial within 4 weeks prior to study initiation;
- • Any of the following cardiovascular or cerebrovascular diseases or risk factors:
- LVEF <50%;
- NYHA Class III or IV heart failure;
Show all 28Show fewer
- History of myocarditis, cardiomyopathy, or myocardial infarction within 6 months prior to enrollment (unless cardiac function has recovered as confirmed by the investigator);
- Uncontrolled arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) or requiring long-term anti-arrhythmic therapy;
- QTcF >480 ms on screening ECG;
- Uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP >100 mmHg);
- History of ischemic or hemorrhagic stroke (unless stable for >6 months with no sequelae);
- Uncontrolled intracranial lesions (e.g., brain tumors, aneurysms);
- History of DVT or PE (unless on stable anticoagulant therapy for ≥6 months);
- Significantly elevated troponin or BNP/NT-proBNP levels suggestive of potential cardiac injury or dysfunction;
- • Non-healing wounds or fractures for a prolonged period;
- • Coagulation disorders or bleeding diathesis;
- • History of substance abuse (including psychiatric drugs) that cannot be discontinued or history of psychiatric disorders;
- • Uncontrolled or active fungal, bacterial, viral, or other infections.
- • Prior anti-tumor treatment-related toxicities not recovered to ≤Grade 1 or to levels specified in the inclusion/exclusion criteria;
- • Known HIV infection; known active syphilis; or active hepatitis B (HBsAg-positive and HBV-DNA ≥500 IU/mL or above the lower limit of detection, whichever is higher) or hepatitis C (anti-HCV-positive and HCV-RNA above the lower limit of detection);
- • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage despite appropriate intervention;
- • Severe allergic reaction history to key study treatments (including fludarabine, cyclophosphamide, mycophenolate sodium, tocilizumab, and anti-infective agents used during preconditioning);
- • Active autoimmune disease requiring systemic treatment within 2 years (including but not limited to autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism); physiologic corticosteroid replacement therapy (e.g., thyroxine, insulin, or corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment;
- • Female participants unwilling to use contraception from informed consent through 6 months after CAR-T cell infusion;
- • Participants with leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active/symptomatic CNS metastases not treated locally;
- • History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment;
- • Clinically significant pulmonary impairment due to lung comorbidities, including but not limited to underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, or severe COPD within 3 months prior to enrollment), any autoimmune, connective tissue, or inflammatory disorders involving the lungs (e.g., rheumatoid arthritis, sarcoidosis), or prior pneumonectomy;
- • Any condition deemed by the investigator to interfere with drug evaluation, participant safety, or study outcomes, or any other condition making the participant unsuitable for the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer
This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (REVO-UWD-01) in the metastatic colorectal cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.
Read the detailed description
The study will use T cells from healthy donors, modified using a novel universal CAR-T technology, to treat metastatic colorectal cancer patients. The antigen-binding site of the CAR molecule recognizes GCC as the target.
The main questions it aims to answer are:
- What is the maximum tolerated dose (MTD) of GCC-CAR-T therapy in universal CAR-T cell treatments?
- What are the dose-limiting toxicities (DLT) and treatment-emergent adverse events (TEAE)?
- What is the treatment\&amp;#39;s efficacy, as measured by objective response rate (ORR) and progression-free survival (PFS)? Researchers will assess whether universal CAR-T cells have good safety and efficacy in treating colorectal cancer, while improving accessibility and lowering treatment costs.
Participants will:
- Receive universal GCC-CAR-T cells through a 3+3 dose escalation scheme.
- Undergo chemotherapy conditioning before CAR-T infusion.
- Be monitored for adverse events, immune response, and disease progression.
The study will collect data on both short-term outcomes (within the first few months post-treatment) and long-term safety and efficacy.
- Being tested
- Universal CAR-T cells injection for treating mCRC
- Keywords
- Universal CAR-T cells, Allogeneic CAR-T therapy, Wondercel REVO U-CAR platform, REVO-UWD-01
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal CAR-T cells injection for treating mCRCBiological
Also called Allogeneic CAR-T cells (REVO-UWD-01)
A novel universal CAR-T platform to treat cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Single dose injection of REVO-UWD-01 | Experimental | Dose escalation will be performed for the single dose injection of REVO-UWD-01 for treating mCRC Receives: Biological: Universal CAR-T cells injection for treating mCRC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The highest dose of GCC-CAR-T cells that can be administered without causing unacceptable side effects, measured during the dose escalation phase.
Measured: Within the first month post-infusion.
Dose-Limiting Toxicities (DLT)
The incidence of treatment-related toxicities that prevent further dose escalation.
Measured: Within the first month post-infusion.
Treatment-Emergent Adverse Events (TEAE)
The frequency and severity of adverse events that arise following the administration of UWD-01-CAR-T cells.
Measured: From the administration of UWD-01 CAR-T cells through six months post-infusion
Secondary outcomes (4)
Objective Response Rate (ORR)
The proportion of patients with a measurable reduction in tumor size (complete or partial response) following GCC-CAR-T therapy.
Measured: Measured at 3 and 6 months after treatment.
Progression-Free Survival (PFS)
The length of time during and after treatment that the patient lives without disease progression.
Measured: From the start of treatment up to 5 years.
Overall Survival (OS)
The duration from the start of treatment to the time of death from any cause.
Measured: From the start of treatment up to maximum follow-up period of five years.
Duration of Response (DOR)
The time from initial tumor response (CR or PR) to disease progression or relapse or any cause of death.
Measured: From the administration of UWD-01 CAR-T cells to a maximum follow-up period of five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start23 Oct 2024
- Primary completion20 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: Because the implementation of the new regulation policy by the Chinese authority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)Studies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wondercel Biotech (ShenZhen)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653010
- Sponsor's protocol ID
- 2024-REVO-UWD-01
- Acronym
- Wondercel-UWD1
- Status last verified
- May 2026
- First submitted
- 17 Oct 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06653010
- Acronym / sponsor ID
- Wondercel-UWD1 / 2024-REVO-UWD-01
- Keywords
- Universal CAR-T cells, Allogeneic CAR-T therapy, Wondercel REVO U-CAR platform, REVO-UWD-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because the implementation of the new regulation policy by the Chinese authority
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wondercel Biotech (ShenZhen)Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Oct 2024 (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 an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (REVO-UWD-01) in the metastatic colorectal cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.
Detailed description
The study will use T cells from healthy donors, modified using a novel universal CAR-T technology, to treat metastatic colorectal cancer patients. The antigen-binding site of the CAR molecule recognizes GCC as the target.
The main questions it aims to answer are:
- What is the maximum tolerated dose (MTD) of GCC-CAR-T therapy in universal CAR-T cell treatments?
- What are the dose-limiting toxicities (DLT) and treatment-emergent adverse events (TEAE)?
- What is the treatment\&amp;#39;s efficacy, as measured by objective response rate (ORR) and progression-free survival (PFS)? Researchers will assess whether universal CAR-T cells have good safety and efficacy in treating colorectal cancer, while improving accessibility and lowering treatment costs.
Participants will:
- Receive universal GCC-CAR-T cells through a 3+3 dose escalation scheme.
- Undergo chemotherapy conditioning before CAR-T infusion.
- Be monitored for adverse events, immune response, and disease progression.
The study will collect data on both short-term outcomes (within the first few months post-treatment) and long-term safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose injection of REVO-UWD-01 | Experimental | Biological: Universal CAR-T cells injection for treating mCRCDose escalation will be performed for the single dose injection of REVO-UWD-01 for treating mCRC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age: ≥18 years and ≤75 years old.
- Pathological Diagnosis: Pathologically confirmed metastatic colorectal cancer with radiographically confirmed metastatic lesions (e.g., CT or MRI).
- GCC Expression: Tumor lesions assessed by immunohistochemistry (IHC) showing GCC expression ≥1+ in ≥50% of the area (randomly select at least 5 fields from tumor regions for evaluation; at least 5 unstained slides must be provided for assessment).
- Measurable Lesions: At least one measurable lesion per RECIST 1.1 criteria; measurable lesions should not have received prior radiotherapy or interventional local therapy (lesions in previously irradiated or locally treated fields may be selected as target lesions if confirmed to have progressed).
- Prior Treatment: Participants with advanced colorectal cancer who have progressed or are intolerant after ≥2 lines of standard therapy (with clear documentation).
Key exclusion criteria (28 listed)
- • Pregnant or breastfeeding women;
- • Received chemotherapy, targeted therapy, monoclonal antibody therapy, or traditional Chinese medicine anti-tumor therapy within 14 days prior to cell collection;
- • Participated in another drug clinical trial within 4 weeks prior to study initiation;
- • Any of the following cardiovascular or cerebrovascular diseases or risk factors:
- LVEF <50%;
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 |
|---|---|---|
| Universal CAR-T cells injection for treating mCRCAlso: Allogeneic CAR-T cells (REVO-UWD-01)A novel universal CAR-T platform to treat cancer patients | Biological | Single dose injection of REVO-UWD-01 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Within the first month post-infusion.
The highest dose of GCC-CAR-T cells that can be administered without causing unacceptable side effects, measured during the dose escalation phase.
Dose-Limiting Toxicities (DLT)
Time frame: Within the first month post-infusion.
The incidence of treatment-related toxicities that prevent further dose escalation.
Treatment-Emergent Adverse Events (TEAE)
Time frame: From the administration of UWD-01 CAR-T cells through six months post-infusion
The frequency and severity of adverse events that arise following the administration of UWD-01-CAR-T cells.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Measured at 3 and 6 months after treatment.
Progression-Free Survival (PFS)
Time frame: From the start of treatment up to 5 years.
Overall Survival (OS)
Time frame: From the start of treatment up to maximum follow-up period of five years.
Duration of Response (DOR)
Time frame: From the administration of UWD-01 CAR-T cells to a maximum follow-up period of five years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for CRC (Colorectal Cancer)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Universal CAR-T cells injection for treating mCRC in people with CRC (Colorectal Cancer) and Metastatic Colorectal Cancer, run by Wondercel Biotech (ShenZhen) at 2 sites 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 22 inclusion and 28 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: paused, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Within the first month post-infusion.). The study lists 3 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 7 May 2026.