CRC (Colorectal Cancer)Early Phase 1NCT06675513
Autologous CAR-T Cells (WD-01) for Metastatic Colorectal Cancer
A Early Phase 1 study testing An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name: in people with CRC (Colorectal Cancer) and Metastatic Colorectal Cancer, run by Wondercel Biotech (ShenZhen) at 1 site in China.
Trial summary
This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (WD-01) in the metastatic colorectal cancer. 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?
- An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name:
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2025to 30 Dec 2029
- 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
- Pathologically confirmed colorectal cancer. Immunohistochemistry (IHC) assessment shows GCC expression in tumor lesions of ≥1+ in an average of over 40% of the area (evaluated by randomly selecting at least five tumor regions).
- Patients with metastatic colorectal cancer who have failed second-line treatment.
- At least one measurable extracranial lesion per RECIST version 1.1 criteria. Expected survival of ≥90 days.
- Normal function of major organs, meeting the following criteria:
- ECOG performance status of 0-1 or KPS score >70.
- Hematology parameters meeting: Hemoglobin (HB) ≥80 g/L, Absolute Neutrophil Count (ANC) ≥1.5 × 10^9/L, Platelets (PLT) ≥80 × 10^9/L, Lymphocytes (LY) ≥0.5 × 10^9/L.
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- Biochemistry parameters meeting: Total Bilirubin (TBIL) ≤2.0 × ULN (upper limit of normal); ALT and AST ≤2.5 × ULN; Serum Creatinine (Cr) ≤1 × ULN, Creatinine Clearance Rate >40 mL/min (by Cockcroft-Gault formula).
- Left ventricular ejection fraction >55%. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last CAR-T administration (women who have undergone sterilization or have been postmenopausal for at least 2 years are considered not of childbearing potential).
- Voluntary participation in the study, with signed informed consent, good compliance, and willingness to cooperate with follow-up.
Who cannot join
- Pregnant or lactating women. Receipt of small molecule chemotherapy, targeted agents, other investigational drugs, or monoclonal antibodies within 14 days prior to cell collection for enrollment.
- Participation in other clinical trials within 4 weeks prior to the start of this study.
- Uncontrolled hypertension that cannot be adequately managed with a single antihypertensive drug (systolic BP >160 mmHg, diastolic BP >100 mmHg), myocardial ischemia or infarction of grade ≥1, arrhythmia of grade ≥1 (including QT interval ≥440 ms), or cardiac insufficiency.
- Long-standing, unhealed wounds or fractures. History of substance abuse that cannot be discontinued or a history of psychiatric disorders.
- Severe intestinal adhesions, bowel obstruction, or conditions that may cause bowel perforation or abdominal wall fistula after treatment.
- Uncontrolled or active fungal, bacterial, viral, or other infections. Grade ≥2 hematologic toxicity or grade ≥3 non-hematologic toxicity at enrollment as per NCI-CTCAE version 5.0 criteria.
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- Known HIV infection or active hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) infection.
- Presence of indwelling catheters or drainage tubes (e.g., biliary drainage tubes or thoracic/abdominal drainage tubes or pericardial catheters). Use of specialized central venous catheters is permitted.
- Severe malnutrition (for patients <70 years, BMI <18.5 kg/m^2; for patients ≥70 years, BMI <20 kg/m^2).
- History of severe allergic reactions to key therapeutic agents in this study (including fludarabine, cyclophosphamide, mesna, tocilizumab, and anti-infective drugs used during preconditioning).
- History of disseminated intravascular coagulation (DIC), deep vein thrombosis, or pulmonary embolism within 6 months prior to enrollment.
- History of autoimmune diseases that cause terminal organ damage or require systemic immunosuppressive/systemic disease-modifying drugs within 2 years prior to enrollment (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
- Any disease that may interfere with the safety or efficacy assessment of the study treatment.
- Female participants who are unwilling to use contraception from the time of consent until 6 months after completing CAR-T cell infusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study on the Safety and Efficacy of GCC Targeting CAR-T Cells (WD-01) for Metastatic Colorectal Cancer
This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (WD-01) in the metastatic colorectal cancer.
Read the detailed description
The study will use autologous T cells collected from enrolled patient, modified using a 2nd generation CAR bearing lentiviral vector, 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 the autologous CAR-T cell treatments? • What are the dose-limiting toxicities (DLT) and treatment-emergent adverse events (TEAE)? • What is the treatment efficacy, as measured by objective response rate (ORR) and progression-free survival (PFS)? Investigators will assess whether the WD-01 CAR-T cells have good safety and efficacy in treating colorectal cancer. Participants will receive WD-01 GCC-CAR-T cells through a 3+3 dose escalation scheme. • Undergo chemotherapy pre-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
- An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name:
- Keywords
- Autologous CAR-T therapy, WD-01, Wondercel
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name:Biological
Autologous WD-01 CAR-T therapy with Wondercel's "Warrior" armor strategy will be explored for its advantage over other armor platforms.
| Study group | Role | What they receive |
|---|---|---|
| Single dose injection of WD-01 | Experimental | Dose escalation will be performed for the single dose injection of WD-01 for treating mCRC Receives: Biological: An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name: |
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 WD-01 CAR-T cells.
Measured: From the administration of WD-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 between 1 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 WD-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 posted5 Nov 2024
- Study start18 May 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2029 (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
- NCT06675513
- Sponsor's protocol ID
- 2024-GCC-WD-01
- Status last verified
- May 2026
- First submitted
- 3 Nov 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 GCC Targeting CAR-T Cells (WD-01) for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06675513
- Acronym / sponsor ID
- 2024-GCC-WD-01
- Keywords
- Autologous CAR-T therapy, WD-01, Wondercel
- 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
- 18 May 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 5 Nov 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 (WD-01) in the metastatic colorectal cancer.
Detailed description
The study will use autologous T cells collected from enrolled patient, modified using a 2nd generation CAR bearing lentiviral vector, 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 the autologous CAR-T cell treatments? • What are the dose-limiting toxicities (DLT) and treatment-emergent adverse events (TEAE)? • What is the treatment efficacy, as measured by objective response rate (ORR) and progression-free survival (PFS)? Investigators will assess whether the WD-01 CAR-T cells have good safety and efficacy in treating colorectal cancer. Participants will receive WD-01 GCC-CAR-T cells through a 3+3 dose escalation scheme. • Undergo chemotherapy pre-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 WD-01 | Experimental | Biological: An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name:Dose escalation will be performed for the single dose injection of WD-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 (9 listed)
- Pathologically confirmed colorectal cancer. Immunohistochemistry (IHC) assessment shows GCC expression in tumor lesions of ≥1+ in an average of over 40% of the area (evaluated by randomly selecting at least five tumor regions).
- Patients with metastatic colorectal cancer who have failed second-line treatment.
- At least one measurable extracranial lesion per RECIST version 1.1 criteria. Expected survival of ≥90 days.
- ECOG performance status of 0-1 or KPS score >70.
- Hematology parameters meeting: Hemoglobin (HB) ≥80 g/L, Absolute Neutrophil Count (ANC) ≥1.5 × 10^9/L, Platelets (PLT) ≥80 × 10^9/L, Lymphocytes (LY) ≥0.5 × 10^9/L.
Key exclusion criteria (14 listed)
- Pregnant or lactating women. Receipt of small molecule chemotherapy, targeted agents, other investigational drugs, or monoclonal antibodies within 14 days prior to cell collection for enrollment.
- Participation in other clinical trials within 4 weeks prior to the start of this study.
- Uncontrolled hypertension that cannot be adequately managed with a single antihypertensive drug (systolic BP >160 mmHg, diastolic BP >100 mmHg), myocardial ischemia or infarction of grade ≥1, arrhythmia of grade ≥1 (including QT interval ≥440 ms), or cardiac insufficiency.
- Long-standing, unhealed wounds or fractures. History of substance abuse that cannot be discontinued or a history of psychiatric disorders.
- Severe intestinal adhesions, bowel obstruction, or conditions that may cause bowel perforation or abdominal wall fistula after 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 |
|---|---|---|
| An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name:Autologous WD-01 CAR-T therapy with Wondercel's "Warrior" armor strategy will be explored for its advantage over other armor platforms. | Biological | Single dose injection of WD-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 WD-01 CAR-T cells through six months post-infusion
The frequency and severity of adverse events that arise following the administration of WD-01 CAR-T cells.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Measured between 1 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 WD-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
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name: in people with CRC (Colorectal Cancer) and Metastatic Colorectal Cancer, run by Wondercel Biotech (ShenZhen) 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 9 inclusion and 14 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 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?
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.