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Study of Anti-5T4 CAR-NK Cell Therapy in Advanced Solid Tumors

NCT05194709 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-02

No results posted yet for this study

Summary

This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors.

Conditions

Interventions

BIOLOGICAL

Anti-CAR-NK Cells

The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle (21 days). The first administration dose in the first cycle is 3.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10\^9 cells.

Sponsors & Collaborators

  • Imbioray (Hangzhou) Biomedicine Co., Ltd.

    collaborator INDUSTRY

  • Wuxi People's Hospital

    lead OTHER

Principal Investigators

  • Peihua P Lu, MD · Wuxi People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

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 NCT05194709 on ClinicalTrials.gov