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Claudin18.2 Positive Advanced Solid TumorsPhase 1NCT06782425

Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)

A Phase 1 study testing XKDCT225 in people with Claudin18.2 Positive Advanced Solid Tumors, run by Shenzhen Celconta Life Science Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
XKDCT225
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Jan 2025to Jan 2028
Phase
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

  • Age 18-75 (including the critical value), regardless of gender;
  • Patients with advanced solid tumors (including but not limited to gastric adenocarcinoma, esophagogastric junction adenocarcinoma, esophageal adenocarcinoma) with moderate to high expression of Claudin18.2 (expression intensity ≥ 2+ and tumor cell positive rate ≥ 50 %), and whose condition cannot be completely relieved or continues to progress after adequate treatment;
  • At least one measurable lesion according to RECIST 1.1 criteria (non-lymph node lesion with long diameter ≥10 mm, lymph node lesion with short diameter ≥15 mm);
  • Estimated life expectancy > 12 weeks;
  • ECOG physical status score 0 ~ 1;
  • Laboratory test values for screening must meet the following criteria:
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  • Routine blood test:
  • WBC≥3.0×10^9 /L
  • ANC≥1.5×10^9 /L
  • LYMPH≥0.5×10^9 /L
  • HB≥90g/L
  • PLT≥75×10^9 /L
  • Blood biochemistry examination:
  • ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis is present)
  • ALB≥30g/L
  • Serum creatinine ≤1.5×ULN or GFR>50mL/min (GFR = [(140-age)×weight×(0.85female)]/(72×Scr))
  • TBIL≤1.5×ULN
  • Coagulation function test:
  • APTT ≤ 1.5 ULN, with INR or PT ≤ 1.5 ULN (not receiving anticoagulation therapy) 7. Female subjects of childbearing age must undergo a serum pregnancy study with negative results at screening and before purging, and be willing to use medically approved highly effective contraceptive methods during the study and for at least 1 year after the last study treatment. Male subjects whose partners are female subjects of childbearing age should undergo surgical sterilization or agree to use effective contraceptive methods during the study and for at least 1 year after the last study treatment, and are prohibited from donating sperm within 1 year.
  • 8. If the patient is using the following medications, the corresponding conditions must be met:
  • Steroids: Therapeutic doses of steroids must be discontinued 4 weeks prior to XKDCT 225 cell injection. However, physiological replacement doses of steroids are allowed: hydrocortisone or equivalent <6~ 12mg / mm^2 / day ;
  • Immunosuppression: Any immunosuppressive drugs must be stopped ≥ 4 weeks before enrollment; 9. Volunteer to participate in the clinical trial and sign the informed consent.

Who cannot join

  • Pregnant or breastfeeding women;
  • Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;
  • Any active infection requiring antibiotic treatment;
  • Received any immune cell therapy within one year;
  • Previously received Claudin18.2 targeted therapy ;
  • Live vaccine or live attenuated vaccine received within 4 weeks before single collection;
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  • Surgery has been performed within 2 weeks before apheresis and the researchers believe that it may affect the patient's safety;
  • Active coronary heart disease (including angina pectoris, myocardial infarction) within 6 months before enrollment;
  • Within 6 months before study entry, the subject had a history of clinically significant arrhythmias or current abnormalities requiring antiarrhythmic treatment other than beta-blockers or digoxin and/or conduction drugs, excluding atrial fibrillation and paroxysmal supraventricular tachycardia;
  • Left ventricular ejection fraction (LVEF) <50% or congestive heart failure (New York Heart Association NYHA classification ≥3) at screening;
  • Uncontrolled diabetes (glycosylated hemoglobin>8%), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure>160mmHg/100mmHg while taking medication);
  • Patients with active autoimmune diseases within 3 months before screening, such as systemic lupus erythematosus, who need to continue taking medication during the entire trial period;
  • Other malignancies occurred within 5 years before enrollment, excluding cervical carcinoma in situ, skin squamous cell carcinoma, or basal cell carcinoma that had been treated with radical cure;
  • Have a known symptomatic central nervous system (CNS) disease;
  • Tumor cells infiltrate the central nervous system, and tumor cells are detected in the cerebrospinal fluid or the tumor is detected by cranial imaging;
  • The tumor has extensive metastasis and involves more than two organs at the same time, which the investigator believes may significantly change the baseline assessment; or the tumor has progressed rapidly and has reached PD between enrollment and lymph node clearance;
  • Difficult airway (tumor growth blocking the airway or airway deformity, etc.);
  • before apheresis, lymph node ablation, and XKDCT 225 cell injection to maintain fingertip blood oxygen saturation > 95%;
  • The subject has unstable or active gastric ulcer or active gastrointestinal bleeding, or other conditions that may require emergency treatment during the trial, including but not limited to gastrointestinal obstruction, perforation, and rupture of giant tumors;
  • Patients with pleural and abdominal effusion greater than grade 2 during screening and unable to be controlled by drainage or diuretics;
  • The subject is currently taking anticoagulants and cannot stop taking them during the entire trial;
  • Allergy or intolerance to the research drugs tocilizumab, fludarabine, cyclophosphamide and other lymphoproliferative drugs selected by the investigator;
  • Those who are allergic to common emergency and anesthetic drugs, and have life-threatening allergic reactions, hypersensitivity reactions, or intolerance to XKDCT 225 cell preparations or their components; Patients who were deemed unsuitable for participation in this study 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.

Baozhong Li contact

13937238883

libaozhong99@126.com

China1 site, 1 recruiting

  • AnYang Tumor Hospital

    Anyang, Henan, 455000

    Baozhong Li, 13937238883, libaozhong99@126.com

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial of the Safety, Efficacy, and Pharmacokinetics of XKDCT225 (Targeting Claudin18.2-CAR-T) Cell Injectionin Claudin18.2-positive Advanced Solid Tumors

A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors

Read the detailed description

This study is a prospective, single-arm, open-label, single-dose dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of XKDCT225 cell injection preparation in subjects with Claudin18.2-positive advanced solid tumors.

The study will enroll subjects with pathologically confirmed advanced solid tumors, positive Claudin18.2 expression, who have previously received standard treatment, failed treatment or cannot tolerate it. Imaging examinations show evaluable tumor lesions.

This study adopts a single-arm, single-center, dose-escalation design, and uses "accelerated titration" and "3+3" trial designs for dose escalation . It is expected to include 9-18 patients to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of XKDCT225 cell injection .

Main purpose:

the safety and tolerability of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies.

Secondary Purpose:

the pharmacokinetic and pharmacodynamic characteristics of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies; To preliminarily evaluate the efficacy of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies.

Being tested
XKDCT225

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XKDCT225Drug

    Autologous targeted claudin18.2 chimeric antigen receptor T cell injection

Study groups in NCT06782425
Study groupRoleWhat they receive
Autologous targeted claudin18.2 chimeric antigen receptor T cell injectionExperimentalAutologous targeted claudin18.2 chimeric antigen receptor T cell injection
Receives: Drug: XKDCT225

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT)

    Dose limiting toxicity (DLT) in the dose escalation phase

    Measured: 28 days of single infusion

  2. Maximum tolerated dose (MTD)

    Maximum tolerated dose (MTD) in the dose escalation phase

    Measured: 28 days of single infusion

  3. The incidence and severity of adverse events (AEs) (%)

    The incidence and severity of AEs

    Measured: 1 year

Secondary outcomes (8)

  1. Pharmacokinetics (the number of CAR copies (copies/μg gDNA) in peripheral blood)

    The number of CAR copies (copies/μg gDNA) were detected by qPCR method to determine the peak time (day) of XKDCT225, sustained survival period (day).

    Measured: 1 year

  2. Peripheral blood cytokines

    Including IL-6 concentration (pg/ml) , etc.

    Measured: 1 year

  3. XKDCT293 immunogenicity assay

    employing a validated electrochemiluminescence (ECL) assay on the MESO QuickPlex SQ 120 system from Meso Scale Discovery (MSD). This assay detects XKDCT293 antibody titer (ng/ml) by measuring the emitted light from the SULFO-TAG label.

    Measured: 1 year

  4. Objective response rate (ORR) (%)

    According to RECIST 1.1 criteria, the percentage of the analyzed population with the best efficacy evaluation reaching CR and PR.

    Measured: 1 year

  5. Time to response (TTR) (month)

    According to RECIST 1.1 criteria, the time interval from the date of initial infusion of the study drug to the date of initial assessment of partial remission or better outcome in patients with the best efficacy evaluation as partial remission or better outcome.

    Measured: 1 year

  6. Duration of Overall Response (DOR) (month)

    According to RECIST 1.1 criteria, in patients with the best efficacy evaluation of CR or PR, the time (month) from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause (whichever occurs first).

    Measured: 1 year

  7. Progression-free survival (PFS) (month)

    From the first infusion of the study drug to the date of the first recorded tumor progression (whether treated or not) or the date of death for any reason, whichever occurs first.

    Measured: 1 year

  8. Overall survival (OS) (month)

    The time between the patient's first infusion of the study drug and the patient's death due to various reasons.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study startJan 2025 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06782425
Sponsor's protocol ID
2023YP30H02
Status last verified
Jan 2025
First submitted
2 Jan 2025
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XKDCT225 in people with Claudin18.2 Positive Advanced Solid Tumors, run by Shenzhen Celconta Life Science 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 22 inclusion and 23 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 17 Jan 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Baozhong Li (13937238883, libaozhong99@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: 28 days of single infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06782425.

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 17 Jan 2025.

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