Colorectal Cancer (CRC)NCT07152210
Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
A study testing CAR-T in people with Colorectal Cancer (CRC), run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.
Trial summary
This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2024to 2 Mar 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this trial, sign the informed consent form.
- Advanced colorectal cancer patients who have either failed standard treatment, experienced intolerable toxicity, or are unsuitable or unwilling to undergo standard treatment, and voluntarily agree to receive the current treatment.
- Be able to provide immunohistochemical (IHC) test results from the past 2 years, indicating positive expression of CDH17/GUCY2C targets in tumor tissues.
- Have at least one extracranial, measurable/assessable lesion according to RECIST 1.1 criteria.
- Have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1 and an expected survival duration of at least 3 months.
- Have recovered from the toxicity associated with previous treatments, with a CTCAE toxicity grade of less than 2.
- Have no significant hematopoietic dysfunction and possess adequate organ function.
- Be able to meet the research center's requirements for apheresis/peripheral blood collection upon successful screening, or have acceptable stored blood cell separation products available.
Who cannot join
- Patients who have had or currently have other malignant tumors within the past five years.
- Presence of brain metastasis.
- History of clinically significant central nervous system disorders, either in the past or at screening.
- Imaging indicating tumor invasion of major blood vessels or indistinct borders with blood vessels.
- Individuals who have received cytotoxic drugs or other interventions, assessed by the investigator as potentially impacting lymphocyte expansion, within 14 days or at least five half-lives (whichever is shorter) prior to blood collection for CAR-T preparation.
- Presence of other viremias.
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- History of severe allergies.
- Patients with severe cardiac disease.
- Patients with severe hepatic and renal dysfunction or disorders of consciousness.
- Patients with active autoimmune or inflammatory diseases.
- Patients with objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, severe lung function impairment, etc.
- Patients who have undergone or are awaiting organ transplantation.
- Infections requiring intravenous antibiotic therapy for control or are uncontrollable.
- Individuals who have received live (attenuated) virus vaccines within four weeks prior to screening.
- Alcoholics or individuals with a history of substance abuse.
- Pregnant or lactating women.
- Individuals who have participated in other clinical trials involving drugs within the past 30 days.
- Patients who, based on the investigator's judgment and/or clinical standards, have contraindications to any study procedures or present other medical conditions that may pose unacceptable risks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- CAR-T
- Keywords
- Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TBiological
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T | Experimental | The dosage range of 1.0 × 10^6/kg (± 20%) to 5.0 × 10^6/kg (± 20%) of CAR-T cells, administered either intravenously or intratumorally. Receives: Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Count the Incidence of adverse events
Measured: Up to 1 year after CAR-T infusion
Effectiveness evaluation
In accordance with the RECIST 1.1 criteria for assessing the efficacy of solid tumors, the objective response rate (ORR), encompassing patients achieving complete response (CR) and partial response (PR).
Measured: Up to 1 years after CAR-T infusion
Secondary outcomes (2)
Pharmacokinetic parameters
The highest concentration of CAR-T cell expansion in peripheral blood after administration
Measured: Up to 1 year after CDH17/GUCY2C CAR-T infusion
Pharmacodynamic parameters
The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ.
Measured: Up to 1 year after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start11 Dec 2024
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Why it stopped: Due to corporate strategic adjustment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152210
- Sponsor's protocol ID
- CF-24-008
- Status last verified
- May 2026
- First submitted
- 26 Aug 2025
- Last updated
- 28 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07152210
- Acronym / sponsor ID
- CF-24-008
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Colorectal cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to corporate strategic adjustment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 3 Sep 2025 (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 study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T | Experimental | Biological: CAR-TThe dosage range of 1.0 × 10^6/kg (± 20%) to 5.0 × 10^6/kg (± 20%) of CAR-T cells, administered either intravenously or intratumorally. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participate in this trial, sign the informed consent form.
- Advanced colorectal cancer patients who have either failed standard treatment, experienced intolerable toxicity, or are unsuitable or unwilling to undergo standard treatment, and voluntarily agree to receive the current treatment.
- Be able to provide immunohistochemical (IHC) test results from the past 2 years, indicating positive expression of CDH17/GUCY2C targets in tumor tissues.
- Have at least one extracranial, measurable/assessable lesion according to RECIST 1.1 criteria.
- Have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1 and an expected survival duration of at least 3 months.
Key exclusion criteria (18 listed)
- Patients who have had or currently have other malignant tumors within the past five years.
- Presence of brain metastasis.
- History of clinically significant central nervous system disorders, either in the past or at screening.
- Imaging indicating tumor invasion of major blood vessels or indistinct borders with blood vessels.
- Individuals who have received cytotoxic drugs or other interventions, assessed by the investigator as potentially impacting lymphocyte expansion, within 14 days or at least five half-lives (whichever is shorter) prior to blood collection for CAR-T preparation.
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 |
|---|---|---|
| CAR-TEligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy. | Biological | CAR-T |
Primary outcome
Evaluation of Safety
Time frame: Up to 1 year after CAR-T infusion
Count the Incidence of adverse events
Effectiveness evaluation
Time frame: Up to 1 years after CAR-T infusion
In accordance with the RECIST 1.1 criteria for assessing the efficacy of solid tumors, the objective response rate (ORR), encompassing patients achieving complete response (CR) and partial response (PR).
2 secondary outcomes
Pharmacokinetic parameters
Time frame: Up to 1 year after CDH17/GUCY2C CAR-T infusion
Pharmacodynamic parameters
Time frame: Up to 1 year after CAR-T infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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 study testing CAR-T in people with Colorectal Cancer (CRC), run by Guangzhou Bio-gene Technology Co., Ltd 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 28 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of Safety (time frame: Up to 1 year after CAR-T infusion). 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 28 May 2026.