An Open-label, Multi-center, Dose-escalation and Expansion, Phase 1/2a Study to Evaluate the Safety, Tolerability, PK/PD, and Preliminary Anti-tumor Activity of GIC-102 Monotherapy in Patients With Advanced Solid Tumors, R/R Non-Hodgkin Lymphoma, and Multiple Myeloma
Overview
- Phase
- Phase 1
- Intervention
- GIC-102
- Conditions
- Advanced Solid Tumors
- Sponsor
- GI Cell, Inc.
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Dose-limiting toxicity assessment (dose escalation phase)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
This is a first-in-human, open-label, non-randomized, dose-escalation and expansion phase 1/2a trial to determine the safety profile and identify the maximum tolerated dose of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma. This study will comprise two phases. * GIC-102 monotherapy dose escalation Phase * GIC-102 monotherapy dose expansion phase GIC-102 is an "off-the-shelf" allogeneic natural killer cells isolated from non-HLA-related healthy donor. Natural killer cells are innate immune cells that show strong cytolytic function against physiologically stressed cells such as tumor cells and virus infected cells.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Clinically significant cardiovascular disease within 24 weeks
- •Primary malignant tumor other than the indications for this study
- •The following diseases
- •Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks
- •The New York Heart Association class III/IV
- •Active hepatitis B virus or hepatitis C virus infection
- •Human immunodeficiency virus positive
- •Clinically significant symptoms or uncontrolled central nervous system metastasis
- •Previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study
- •Received chemotherapy other than pre-conditioning within 4 weeks
Arms & Interventions
Dose escalation phase: GIC-102 monotherapy
* Low Dose level 1: 1 x 10\^9 cells * Mid Dose level 2: 3 x 10\^9 cells * High Dose level 3: 1 x 10\^10 cells
Intervention: GIC-102
Dose expansion phase: GIC-102 monotherapy
- Dose level: RP2D
Intervention: GIC-102
Outcomes
Primary Outcomes
Dose-limiting toxicity assessment (dose escalation phase)
Time Frame: Up to 4 weeks
To determine the maximum tolerated dose of allogeneic natural killer cells
Adverse event / Immune related adverse event
Time Frame: through study completion, an average of 1 year
To determine the safety of GIC-102
Objective Response Rate (ORR) (dose expansion phase)
Time Frame: through study completion, an average of 1 year
To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)
Secondary Outcomes
- PK Profile (dose expansion phase) - Tmax(up to 6 months)
- Overall survival (OS)(Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase))
- Duration of response (DOR)(Through study completion)
- PK Profile (dose expansion phase) -Cmax(up to 6 months)
- PK Profile (dose expansion phase) - AUC(up to 6 months)
- Objective response rate (ORR) (dose escalation phase)(through study completion, an average of 1 year)
- Progression free survival (PFS)(Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase))
- Disease Control Rate (DCR)(through study completion, an average of 1 year)