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An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects

NCT05277987 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-03-14

No results posted yet for this study

Summary

An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects. To evaluate the tolerability and safety of different doses of HEC-016 CAR-T cell injections in patients with advanced gastric / esophagogastric junction adenocarcinoma and pancreatic cancer, to observe dose limiting toxicity (DLT), to determine the maximum tolerated dose (MTD) and to recommend the regimen for subsequent clinical trials.

Conditions

  • CAR T-Cell Therapy

Interventions

DRUG

HEC-016(0.5×10^6 CAR-T Cells)

The initial dose is set to 0.5 × 10\^6 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in the dose group. DLT was observed within 28 days after cell infusion.

DRUG

HEC-016(0.5×10^6.5 CAR-T Cells)

The Second dose is set 0.5 × 10\^6.5 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in the dose group.

DRUG

HEC-016(0.5×10^7 CAR-T Cells)

The Third dose is set 0.5 × 10\^7 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in the dose group.

Sponsors & Collaborators

  • Shenzhen Fifth People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05277987 on ClinicalTrials.gov