Actively Recruiting
An Open-label, Multi-center, Dose-escalation and Expansion Phase 1/2a Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of GIC-102 in Advanced Solid Tumors, Relapsed/Refractory Non-Hodgkin Lymphoma, and Multiple Myeloma
Led by GI Cell, Inc. · Updated on 2024-07-09
50
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GIC-102, an off-the-shelf allogeneic natural killer cell therapy, in patients with advanced solid tumors, relapsed or refractory non-Hodgkin lymphoma, and multiple myeloma. This first-in-human, open-label, phase 1/2a trial aims to study the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor effects of GIC-102. The trial is sponsored by GI Cell, Inc. and includes dose escalation and expansion phases to identify the maximum tolerated dose and evaluate treatment effects. GIC-102 is administered intravenously as monotherapy, given three times at one-week intervals, with 28 days considered one treatment cycle. The study has a dose escalation phase with low, mid, and high dose levels ranging from 1 x 10^9 to 1 x 10^10 cells, followed by a dose expansion phase using the recommended phase 2 dose. This design allows careful assessment of safety and initial treatment activity at different doses. Participants will undergo assessments for adverse events, immune-related effects, and objective response rates throughout the study, which typically lasts about one year. Researchers will monitor pharmacokinetic profiles, disease control, progression-free survival, overall survival, and duration of response. The study includes safety monitoring during and after treatment, with evaluations occurring at regular intervals to track effects and treatment tolerance.
CONDITIONS
Brief Title
GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 19 years of age
- Diagnosis of advanced solid tumors, relapsed/refractory non-Hodgkin lymphoma, or multiple myeloma
- At least one measurable or evaluable lesion
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of 12 weeks or more
- Acceptable blood, kidney, and liver function
- Willingness to sign informed consent form
You will not qualify if you...
- Clinically significant cardiovascular disease within the past 24 weeks
- Primary malignant tumors other than the study indications
- Severe infection or uncontrolled active infection requiring systemic antibiotics or antivirals within 4 weeks
- New York Heart Association class III or IV heart disease
- Active hepatitis B or C infection
- HIV positive status
- Clinically significant symptoms or uncontrolled central nervous system metastasis
- Diagnosed immunodeficiency or need for systemic corticosteroids or immunosuppressants within 2 weeks or during study
- Received chemotherapy (other than pre-conditioning) within 4 weeks
- Major surgery within 4 weeks or minor surgery within 2 weeks
- Hypersensitivity to study drug, excipients, cyclophosphamide, or fludarabine
- Prior allogeneic cell therapy within 6 months or autologous stem cell transplant within 4 weeks
- Previous allogeneic tissue or solid organ transplant
- Use of other investigational drugs or devices within 4 weeks
- Pregnant or lactating females
- Male subjects not agreeing to contraception or abstinence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive GIC-102 via intravenous infusion 3 times at intervals of 1 week, with 28 days defined as 1 cycle.
3 infusion visits per cycle at weekly intervals
Duration - Up to 1 year after treatment completion
Participants are monitored for safety, tolerability, and anti-tumor activity after treatment completion.
Visits as scheduled for safety and efficacy assessments
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
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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