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Study of Anti-5T4 CAR-raNK Cell Therapy in Locally Advanced or Metastatic Solid Tumors

NCT05137275 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-10-27

No results posted yet for this study

Summary

This study is a multicenter, open-label, investigator-initiated trial (IIT), divided into dose escalation (Part A) and dose extension (Part B) phases to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacokinetics (PD) and initial efficacy of conjugated antibody redirecting ready-to-use allogeneic NK (CAR-raNK) cells that target trophoblast glycoprotein (5T4) in patients with locally advanced or metastatic solid tumors.

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Interventions

BIOLOGICAL

Anti-5T4 CAR-raNK Cells

In the 3+3 dose escalation study, the minimum initial dose is 3.0×10\^9 cells and then escalate to 6.0× 10\^9 and 9.0× 10\^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 3\\8 of each cycle. In dose extension study, the initial dose will be determined by RP2D determined by the results of dose escalation study, and the other intervention methods are consistent.

Sponsors & Collaborators

  • Imbioray (Hangzhou) Biomedicine Co., Ltd.

    collaborator INDUSTRY

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Jin Li, PhD · Shanghai East Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2023-04-30
Completion
2023-05-31

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 NCT05137275 on ClinicalTrials.gov