Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of XKDCT086 (iPD-1-Claud… (NCT05952375) | Clinical Trial Compass
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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
China9 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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:
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events (AE)
Timeframe: 12 months
Trial details
NCT IDNCT05952375
SponsorThe Affiliated Hospital of Qingdao University