Actively Recruiting

Phase 1
Phase 2
Age: 19Years +
All Genders
NCT05880043

GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies

Led by GI Cell, Inc. · Updated on 2024-07-09

50

Participants Needed

4

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.

CONDITIONS

Official Title

GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 19 years of age
  • Diagnosed with advanced solid tumors, relapsed or refractory non-Hodgkin lymphoma, or multiple myeloma
  • Have at least one measurable or evaluable tumor lesion
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy of 12 weeks or more
  • Acceptable blood, kidney, and liver function
  • Willing and able to sign informed consent form
Not Eligible

You will not qualify if you...

  • Clinically significant cardiovascular disease within the past 24 weeks
  • Have a primary malignant tumor other than the study indications
  • Have severe infection or uncontrolled active infection requiring systemic antibiotics or antivirals within 4 weeks
  • New York Heart Association class III or IV heart failure
  • Active hepatitis B or hepatitis C infection
  • HIV positive
  • Clinically significant or uncontrolled central nervous system metastasis
  • Diagnosed with immunodeficiency or need systemic corticosteroids or other immunosuppressants within 2 weeks or during the study
  • Received chemotherapy other than pre-conditioning within 4 weeks
  • Major surgery within 4 weeks or minor surgery within 2 weeks before study
  • Allergic reactions to the study drug or its ingredients
  • Allergic to cyclophosphamide or fludarabine
  • Received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks
  • Previously received allogeneic tissue or solid organ transplant
  • Used other investigational drugs or devices within 4 weeks
  • Pregnant or breastfeeding women
  • Male subjects not agreeing to use contraception or abstain

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Korea University Anam Hospital

Seoul, South Korea

Actively Recruiting

2

Seoul Asan Medical center

Seoul, South Korea

Actively Recruiting

3

Seoul Asan Medical center

Seoul, South Korea

Not Yet Recruiting

4

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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