CDH17-positive Advanced Solid TumorsEarly Phase 1NCT06820424
Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors
A Early Phase 1 study testing Anti-CDH17 CAR-T cells infusion in people with CDH17-positive Advanced Solid Tumors, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
Trial summary
This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CDH17-positive Advanced Solid Tumors
- What is being tested?
- Anti-CDH17 CAR-T cells infusion
- 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
- Mar 2025to Jun 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
- The patient understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedures;
- Age 18-75 years old, gender unlimited;
- Tumor patients who have positive expression of CDH17 target in tumor tissues measured by immunohistochemistry (IHC) in a laboratory approved by the partner, and have no standard therapy or are ineffective or not suitable for standard treatment;
- Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;
- Estimated survival ≥ 12 weeks;
- Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point;
- The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade < 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
- Venous access could be established; without contraindications of apheresis.
Who cannot join
- Patients with prior or current other malignancies;
- Presence of brain metastases and clinically significant central nervous system disease;
- Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
- Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution
- Those who have a positive sputum smear and T-cell test for tuberculosis infection;
- Patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function, both past and present;
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- Patients have a severe allergic history;
- Patients with severe heart disease or uncontrollable refractory hypertension;
- Patients with severe liver and kidney dysfunction or consciousness disorders;
- Active autoimmune or inflammatory diseases of the nervous system;
- Uncontrolled infections that need antibiotics treatment;
- Live attenuated vaccine within 4 weeks before screening;
- Alcoholics or persons with a history of drug abuse;
- Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;
- Any unsuitable to participate in this trial judged by the investigator.
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
Sanbin Wang
Kunming, Yunnan, 650100
Sanbin Wang Wang, MD, 13187424131, Sanbin1011@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors
This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.
Read the detailed description
This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.A leukapheresis procedure will be performed to manufacture Anti-CDH17 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-CDH17 CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.
- Conditions
- CDH17-positive Advanced Solid Tumors
- Being tested
- Anti-CDH17 CAR-T cells infusion
- Keywords
- CDH17 CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CDH17 CAR-T cells infusionBiological
Subiects who meet the enrollment conditions will receive intravenous infusion of anti-CDH17 CAR-T Cells after lymphodepleting therapy.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CDH17 CAR-T cells | Experimental | CDH17 CAR-T is a novel CAR cell therapy for the treatment of advanced solid tumors. Receives: Biological: Anti-CDH17 CAR-T cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome are graded by American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Measured: within 52 weeks post-infusion
Secondary outcomes (4)
Objective Response Rate (ORR)
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Measured: within 52 weeks post-infusion
Concentration of CAR-T cells
Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion
Measured: Days 2, 5, 8, 11, 14, 21, 28, 35 and weeks 6, 12, 18, 26, 34, 42, 52 after infusion
Progression-free survival(PFS)
Progression-free survival(PFS) refers to the time from cell reinfusion to the first assessment of tumor progression or death from any cause.
Measured: within 52 weeks post-infusion
Overall survival(OS)
Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-T cells until death (from any cause).
Measured: within 52 weeks post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CDH17-positive 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Bio-gene Technology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, MD, Principal investigator, Principal Investigator Sanbin Wang 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820424
- Sponsor's protocol ID
- BG-CT-22-013
- Status last verified
- Jan 2025
- First submitted
- 6 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06820424
- Acronym / sponsor ID
- BG-CT-22-013
- Conditions
- CDH17-positive Advanced Solid Tumors
- Keywords
- CDH17 CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Collaborators
- Guangzhou Bio-gene Technology Co., Ltd
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Feb 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 is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.
Detailed description
This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.A leukapheresis procedure will be performed to manufacture Anti-CDH17 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-CDH17 CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CDH17 CAR-T cells | Experimental | Biological: Anti-CDH17 CAR-T cells infusionCDH17 CAR-T is a novel CAR cell therapy for the treatment of advanced solid tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedures;
- Age 18-75 years old, gender unlimited;
- Tumor patients who have positive expression of CDH17 target in tumor tissues measured by immunohistochemistry (IHC) in a laboratory approved by the partner, and have no standard therapy or are ineffective or not suitable for standard treatment;
- Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;
- Estimated survival ≥ 12 weeks;
Key exclusion criteria (15 listed)
- Patients with prior or current other malignancies;
- Presence of brain metastases and clinically significant central nervous system disease;
- Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
- Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution
- Those who have a positive sputum smear and T-cell test for tuberculosis infection;
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 |
|---|---|---|
| Anti-CDH17 CAR-T cells infusionSubiects who meet the enrollment conditions will receive intravenous infusion of anti-CDH17 CAR-T Cells after lymphodepleting therapy. | Biological | Anti-CDH17 CAR-T cells |
Primary outcome
Incidence of adverse events(AE) after infusion
Time frame: within 52 weeks post-infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome are graded by American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: within 52 weeks post-infusion
Concentration of CAR-T cells
Time frame: Days 2, 5, 8, 11, 14, 21, 28, 35 and weeks 6, 12, 18, 26, 34, 42, 52 after infusion
Progression-free survival(PFS)
Time frame: within 52 weeks post-infusion
Overall survival(OS)
Time frame: within 52 weeks post-infusion
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 11 Feb 2025.
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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.
Sanbin Wang, MD principal investigator
Principal Investigator Sanbin Wang 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
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 Anti-CDH17 CAR-T cells infusion in people with CDH17-positive Advanced Solid Tumors, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 15 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 11 Feb 2025. 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 Sanbin Wang, MD (13187424131, Sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events(AE) after infusion (time frame: within 52 weeks post-infusion). 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 11 Feb 2025.