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RD07 Cell Injection in the Treatment of Patients With Advanced Claudin18.2 Positive Solid Tumors

NCT05284968 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-03-17

No results posted yet for this study

Summary

IP: RD07 cell injection; Target disease：solid tumor; Protocol design： Single arm, open label, dose increasing design. The experiment was divided into two stages: dose increasing stage and dose extension stage. After the completion of the dose escalation phase (9 or 12 cases) and the conclusion of safety, the investigator can select the appropriate dose group according to the safety, tolerance, and treatment response to enter the dose expansion phase. Dose extension stage (24 and 27 cases) according to the indications in the crowd into three queues: respectively for the integration of a stomach and the stomach esophagus adenocarcinoma, pancreatic cancer and other solid tumor, expand stage each queue number of cases can be determined by the actual filter and into the group of patients, no separate regulation, but two phase of the total case must not exceed 36 cases.

Conditions

Interventions

DRUG

Cell injection

All subjects will be treated with cell injection

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-05-01
Completion
2025-04-01

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Entities

Diseases

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 NCT05284968 on ClinicalTrials.gov