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

ConditionsAdvanced Solid Tumors Relapsed/Refractory Non-Hodgkin Lymphoma Relapsed/Refractory Multiple Myeloma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age19+

SponsorGI Cell, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 19 years of age

Advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma

At least one measurable or evaluable lesion

Eastern Cooperative Oncology Group performance status 0 or 1

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

GIC-102
Drug
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle
GIC-102
Drug
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Dose escalation phase: GIC-102 monotherapyExperimental treatment 1 intervention

Group B: Dose expansion phase: GIC-102 monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Dose-limiting toxicity assessment (dose escalation phase)

To determine the maximum tolerated dose of allogeneic natural killer cells

Time frame

Up to 4 weeks

Adverse event / Immune related adverse event

To determine the safety of GIC-102

Time frame

through study completion, an average of 1 year

Objective Response Rate (ORR) (dose expansion phase)

To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)

Time frame

through study completion, an average of 1 year

Secondary outcomes

Objective response rate (ORR) (dose escalation phase)

To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)

Time frame

through study completion, an average of 1 year

Progression free survival (PFS)

Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first

Time frame

Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase)

Overall survival (OS)

Duration from start of study treatment to death (regardless of cause)

Time frame

Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase)

Duration of response (DOR)

Time from the first occurrence of a documented objective response to the time of the first document disease progression or death from any cause

Time frame

Through study completion

Other outcomes

PK Profile (dose escalation phase) -Cmax

Time frame

up to 6 months

PK Profile (dose escalation phase) - Tmax

Time frame

up to 6 months

PK Profile (dose escalation phase) - AUC

Time frame

up to 6 months

Immune Profile

* Immune response activation factor (Immune subset marker, cytokine expression) * Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GI Cell, Inc.

Lead sponsor

Source ClinicalTrials.gov

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