Gastric CancerNCT05952375
Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of XKDCT086 (iPD-1-Claudin18.2-CAR-T) in Claudin 18.2 Positive Advanced Solid Malignant Tumors: a Single Center, Single Arm, Dose-increasing Trial
A study testing Chimeric antigen receptor T cell preparation targeting Claudin18.2 in people with Gastric Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The goal of this clinical trial is to assessing the safety and tolerability of XKDCT086 cells against recurrent or refractory solid tumors with Claudin18.2 positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting Claudin18.2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Chimeric antigen receptor T cell preparation targeting Claudin18.2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 28 Feb 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age range from 18 to 75 years old (including threshold), regardless of gender;
- 2. Patients with advanced solid malignant tumors with positive expression of Claudin 18.2 (including but not limited to gastric cancer, esophageal gastric junction adenocarcinoma, and esophageal adenocarcinoma); And after sufficient treatment, the condition cannot be completely relieved or continue to progress;;
- 3. At least one measurable lesion (non lymph node lesion with a length diameter of ≥ 10mm and lymph node lesion with a short diameter of ≥ 15mm) using the RECIST 1.1 standard;
- 4. Expected survival time ≥ 12 weeks;
- 5. ECOG score 0-1 points;
- 6. The laboratory test values conducted for screening must meet the following standards:
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- Blood routine examination:
- WBC ≥ 3.0 × 10^9/L
- ANC ≥ 1.5 × 10^9/L
- HB ≥ 80g/L (no blood transfusion received within 2 weeks)
- PLT ≥ 100 × 10^9/L
- Blood biochemical examination:
- ALT and AST ≤ 2.5 × ULN (≤ 5 if accompanied by liver metastasis) × ULN
- ALB ≥ 30g/L
- Serum creatinine ≤ 1.5 × ULN or GFR>50mL/min (GFR=[(140 age) × weight × (0.85 female)]/(72 × Scr)
- TBIL ≤ 1.5 × ULN
- Coagulation function test:
- APTT ≤ 1.5ULN, while INR or PT ≤ 1.5ULN (without receiving anticoagulant therapy)
- 7. Women of childbearing age must undergo serum pregnancy tests during screening and before receiving clearance treatment, and the results must be negative;
- 8. If the patient uses the following drugs, the corresponding situation must be met:
- Steroids: Treatment doses of steroids must be discontinued 4 weeks before XKDCT086 infusion. However, physiological alternative doses of steroids are allowed: hydrocortisone or equivalent<6-12mg/mm2/day;
- Immunosuppression: Any immunosuppressive drug must be stopped at least 4 weeks before enrollment;
- 9. Voluntarily participate in clinical trials and sign an informed consent form.
Who cannot join
- 1. Pregnant or lactating women;
- 2. Active hepatitis B, hepatitis C or other infectious diseases (syphilis, HIV)
- 3. Any active infection that requires antibiotic treatment;
- 4. Have received any immune cell therapy within one year;
- 5. Those who had received PD-1/PD-L1 Targeted therapy in the past and had serious adverse reactions (the investigator judged whether they were suitable for inclusion);
- 6. Have received Targeted therapy drugs of Claudin18.2 in the past;
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- 7. Inoculate with live vaccines or attenuated live vaccines within 4 weeks before single collection;
- 8. Allergic or intolerant to the research drug Tocilizumab, fludarabine, Cyclophosphamide and other anti drenching drugs selected by the researcher;
- 9. Uncontrolled cardio cerebral Vascular disease, such as heart failure or others, existed within 6 months before enrollment;
- 10. Within the 6 months prior to enrollment in the study, the subjects had a clinically significant history of arrhythmia or were currently in need of treatment β Abnormalities of antiarrhythmic therapy other than receptor blockers or Digoxin and/or conduction drugs, except atrial fibrillation and paroxysmal supraventricular tachycardia;
- 11. Left ventricular Ejection fraction (LVEF)<50% at screening;
- 12. Patients with active autoimmune diseases, such as systemic lupus erythematosus, within the first 3 months of screening; Those who require continuous medication throughout the entire trial period;
- 13. Before single collection, oxygen inhalation is required to maintain a fingertip blood oxygen saturation of ≥ 95%;
- 14. Other malignant tumors occurred within 5 years before enrollment, except for cervical Carcinoma in situ, Cutaneous squamous-cell carcinoma or Basal-cell carcinoma which had been treated for radical treatment before;
- 15. Suffering from known symptomatic central nervous system (CNS) diseases;
- 16. Surgery was performed within 2 weeks prior to single collection and the researchers believe it may affect patient safety;
- 17. The maximum target lesion is greater than 40mm;
- 18. The widespread metastasis of tumors involving more than two organs may significantly alter the baseline assessment, the researchers believe; Or the tumor progression is rapid, and from enrollment to clearance, the tumor has reached PD;
- 19. Those whose hydrothorax and ascites are greater than grade 2 and cannot be controlled by discharge or Diuretic;
- 20. Tumor cells infiltrate the central nervous system, and tumor cells are detected in cerebrospinal fluid or detected on cranial imaging;
- 21. The subject has unstable or active gastric ulcers or active gastrointestinal bleeding, or other situations that may require emergency treatment during the trial period, including but not limited to gastrointestinal obstruction, perforation, and massive tumor rupture;
- 22. The subject has been taking Anticoagulant all the time and cannot stop taking the drug during the whole test process.
- 23. Uncontrollable diabetes (Glycated hemoglobin>8%), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure>160mmHg/100mmHg under medication);
- 24. Difficult airways (tumor growth obstructs airways or airway deformities, etc.);
- 25. People who are allergic to commonly used first aid and Narcotic;
- According to the judgment of the researcher, patients who are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
YU cao, 18661809090, caoyu1767@126.com
About this study
The goal of this clinical trial is to assessing the safety and tolerability of XKDCT086 cells against recurrent or refractory solid tumors with Claudin18.2 positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting Claudin18.2.
Read the detailed description
This study adopts a single arm, single center, and dose increasing design, using a "3+3" design for dose increasing to evaluate the safety, tolerance, and effectiveness of XKDCT086 cells, as well as to evaluate the pharmacokinetic characteristics of XKDCT086 cells, the correlation between cytokines and efficacy, and immunogenicity.
The experimental process of this study is divided into seven stages: screening period, blood collection period, baseline period, clearance period, study treatment and safety observation period after treatment, follow-up period, and long-term follow-up.
- Conditions
- Gastric Cancer
- Being tested
- Chimeric antigen receptor T cell preparation targeting Claudin18.2
- Keywords
- Chimeric Antigen
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric antigen receptor T cell preparation targeting Claudin18.2Drug
Chimeric antigen receptor T cell preparation targeting Claudin18.2
| Study group | Role | What they receive |
|---|---|---|
| XKDCT086 treatment for patients with Claudin18.2 target positivity | Experimental | Drug: XKDCT086 (chimeric antigen receptor T cell preparation targeting Claudin18.2)
Dosage form: Cell suspension
Dose: 30-50mL/bag
Medication method: intravenous drip
Frequency: Once Receives: Drug: Chimeric antigen receptor T cell preparation targeting Claudin18.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
- characterize the safety profile of XKDCT086 in patients with advanced solid tumor
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YU cao, MD, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952375
- Sponsor's protocol ID
- XKDCT086
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of XKDCT086 (iPD-1-Claudin18.2-CAR-T) in Claudin 18.2 Positive Advanced Solid Malignant Tumors: a Single Center, Single Arm, Dose-increasing Trial
- ClinicalTrials.gov ID
- NCT05952375
- Acronym / sponsor ID
- XKDCT086
- Conditions
- Gastric Cancer
- Keywords
- Chimeric Antigen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 19 Jul 2023 (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.
The goal of this clinical trial is to assessing the safety and tolerability of XKDCT086 cells against recurrent or refractory solid tumors with Claudin18.2 positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting Claudin18.2.
Detailed description
This study adopts a single arm, single center, and dose increasing design, using a "3+3" design for dose increasing to evaluate the safety, tolerance, and effectiveness of XKDCT086 cells, as well as to evaluate the pharmacokinetic characteristics of XKDCT086 cells, the correlation between cytokines and efficacy, and immunogenicity.
The experimental process of this study is divided into seven stages: screening period, blood collection period, baseline period, clearance period, study treatment and safety observation period after treatment, follow-up period, and long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XKDCT086 treatment for patients with Claudin18.2 target positivity | Experimental | Drug: Chimeric antigen receptor T cell preparation targeting Claudin18.2Drug: XKDCT086 (chimeric antigen receptor T cell preparation targeting Claudin18.2) Dosage form: Cell suspension Dose: 30-50mL/bag Medication method: intravenous drip Frequency: Once |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 1. Age range from 18 to 75 years old (including threshold), regardless of gender;
- 2. Patients with advanced solid malignant tumors with positive expression of Claudin 18.2 (including but not limited to gastric cancer, esophageal gastric junction adenocarcinoma, and esophageal adenocarcinoma); And after sufficient treatment, the condition cannot be completely relieved or continue to progress;;
- 3. At least one measurable lesion (non lymph node lesion with a length diameter of ≥ 10mm and lymph node lesion with a short diameter of ≥ 15mm) using the RECIST 1.1 standard;
- 4. Expected survival time ≥ 12 weeks;
- 5. ECOG score 0-1 points;
Key exclusion criteria (26 listed)
- 1. Pregnant or lactating women;
- 2. Active hepatitis B, hepatitis C or other infectious diseases (syphilis, HIV)
- 3. Any active infection that requires antibiotic treatment;
- 4. Have received any immune cell therapy within one year;
- 5. Those who had received PD-1/PD-L1 Targeted therapy in the past and had serious adverse reactions (the investigator judged whether they were suitable for inclusion);
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 |
|---|---|---|
| Chimeric antigen receptor T cell preparation targeting Claudin18.2Chimeric antigen receptor T cell preparation targeting Claudin18.2 | Drug | XKDCT086 treatment for patients with Claudin18.2 target positivity |
Primary outcome
Adverse Events (AE)
Time frame: 12 months
o characterize the safety profile of XKDCT086 in patients with advanced solid tumor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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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.
YU cao, MD principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chimeric antigen receptor T cell preparation targeting Claudin18.2 in people with Gastric Cancer, run by The Affiliated Hospital of Qingdao University 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 23 inclusion and 26 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 19 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YU cao, MD (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) (time frame: 12 months). 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 19 Jul 2023.