Health TrialsbyHealthPanel

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

ConditionClaudin18.2 Positive Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Celconta Life Science Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • XKDCT225

    Drug

    Autologous targeted claudin18.2 chimeric antigen receptor T cell injection

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Autologous targeted claudin18.2 chimeric antigen receptor T cell injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity (DLT)

Dose limiting toxicity (DLT) in the dose escalation phase

Time frame
28 days of single infusion
2

Maximum tolerated dose (MTD)

Maximum tolerated dose (MTD) in the dose escalation phase

Time frame
28 days of single infusion
3

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

The incidence and severity of AEs

Time frame
1 year

Secondary outcomes

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).

Time frame
1 year
2

Peripheral blood cytokines

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

Time frame
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.

Time frame
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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Celconta Life Science Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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