Advanced Solid TumorEarly Phase 1NCT05515185
B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors
A Early Phase 1 study testing KT095 CAR-T injection in people with Advanced Solid Tumor, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
This is a clinical study to evaluate the safety and efficacy of CAR-T cells in the treatment of patients with advanced solid tumors in China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- KT095 CAR-T injection
- 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
- 9 Sep 2022to 8 Sep 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 and of both sexes;
- Advanced solid tumor diagnosed by histology or pathology;
- Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;
- B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.
- Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;
- The ECOG score is 0-2, and the expected survival time is more than 12 weeks;
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- Laboratory test results should at least meet the following requirements:
- Left ventricular ejection fraction ≥40%; Creatinine ≤200 umol/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L; Hemoglobin ≥80g/L; Oxygen saturation of blood 91%; Total bilirubin ≤2×ULN; ALT and AST 2.5 x ULN or less; The criteria for abnormal ALT and AST due to disease (e.g., liver metastases or bile duct obstruction) or Gilbert syndrome can be relaxed to ≤5×ULN.
- Having venous access for blood collection or single blood collection;
- The patient voluntarily participated and signed the informed consent in person.
Who cannot join
- pregnant or lactating women;
- Chemotherapy or radiotherapy was used within 3 days before the blood collection period;
- Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids);
- Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period;
- Those who have used any gene or cell therapy products;
- History of epilepsy or other central nervous system diseases;
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- Active hepatitis B or C virus, defined as: hepatitis B surface antigen HBsAg or hepatitis B core antibody HBcAb positive subjects with peripheral blood HBV DNA titer above the detection limit; HCV antibody positive for hepatitis C and HCV RNA positive in peripheral blood; People infected with HIV and syphilis;
- Other tumors in the past 5 years;
- Patients with severe chest and ascites;
- There was active or uncontrollable infection requiring systemic treatment within 14 days before enrollment;
- Other antineoplastic treatments (other than pretreatment and chemotherapy) were administered within 2 weeks before study initiation;
- The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222000
yi zhu, PhD, 13871188115, zhuyi@cart-med.com
About this study
Official title: An Open, Single-arm Clinical Study of Autologous T Cells (CAR-T) Targeting B7-H3 Chimeric Antigen Receptor Gene in the Treatment of Patients With Advanced Gastrointestinal Tumors
This is a clinical study to evaluate the safety and efficacy of CAR-T cells in the treatment of patients with advanced solid tumors in China.
Read the detailed description
This is a single-center, single-arm, open-label study. This study is planned to enroll about 30 subjects with advanced solid tumors. Autologous CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.
- Conditions
- Advanced Solid Tumor
- Being tested
- KT095 CAR-T injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT095 CAR-T injectionDrug
Also called Fludarabine, Cyclophosphamide
Clearance of lymphocytes
| Study group | Role | What they receive |
|---|---|---|
| KT095 CAR-T | Experimental | KT095 CAR-T injection Intravenous infusion Receives: Drug: KT095 CAR-T injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
DLT
Measured: Up to 2 years
Maximum tolerable dose
MTD
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start9 Sep 2022 (estimated)
- Primary completion8 Sep 2024 (estimated)
- Study completion8 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515185
- Sponsor's protocol ID
- KT095
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 25 Aug 2022
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm Clinical Study of Autologous T Cells (CAR-T) Targeting B7-H3 Chimeric Antigen Receptor Gene in the Treatment of Patients With Advanced Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT05515185
- Acronym / sponsor ID
- KT095
- Conditions
- Advanced Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 9 Sep 2022 (estimated)
- Primary completion
- 8 Sep 2024 (estimated)
- Study completion
- 8 Sep 2024 (estimated)
- First posted
- 25 Aug 2022 (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 clinical study to evaluate the safety and efficacy of CAR-T cells in the treatment of patients with advanced solid tumors in China.
Detailed description
This is a single-center, single-arm, open-label study. This study is planned to enroll about 30 subjects with advanced solid tumors. Autologous CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KT095 CAR-T | Experimental | Drug: KT095 CAR-T injectionKT095 CAR-T injection Intravenous infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-70 and of both sexes;
- Advanced solid tumor diagnosed by histology or pathology;
- Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;
- B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.
- Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;
Key exclusion criteria (12 listed)
- pregnant or lactating women;
- Chemotherapy or radiotherapy was used within 3 days before the blood collection period;
- Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids);
- Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period;
- Those who have used any gene or cell therapy products;
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 |
|---|---|---|
| KT095 CAR-T injectionAlso: Fludarabine, CyclophosphamideClearance of lymphocytes | Drug | KT095 CAR-T |
Primary outcome
Dose-limiting toxicity
Time frame: Up to 2 years
DLT
Maximum tolerable dose
Time frame: Up to 2 years
MTD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- 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.
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 KT095 CAR-T injection in people with Advanced Solid Tumor, run by The First People's Hospital of Lianyungang 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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Aug 2022. 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?
Contact xiaodong jiang, PhD (0518-85767557, irb_lygyyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Up to 2 years). 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 25 Aug 2022.