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Advanced Solid TumorsPhase 1/2NCT05880043

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

A Phase 1/2 study testing GIC-102 in people with Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma, run by GI Cell, Inc. at 4 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
GIC-102
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesSouth Korea
Study dates
28 Apr 2023to 30 Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • A life expectancy of 12 weeks or more
  • Acceptable hematological function, kidney, and liver function
  • Subjects who sign on an informed consent form willingly

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks
  • Hypersensitivity reactions to the study drug or excipients
  • Hypersensitivity to cyclophosphamide or fludarabine
  • Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks
  • Have previously received an allogeneic tissue/solid organ transplant
  • Have administered other investigational drug or applied other investigational medical device within 4 weeks
  • Pregnant or lactating female subjects
  • Male subjects who did not agree to use contraception or to maintain abstinence

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites, 4 recruiting

  • Korea University Anam Hospital

    Seoul

    Soo-Hyeon Lee, M.D Ph.D, +82 02-920-5690, soohyeon_lee@korea.ac.kr

    Recruiting

  • Seoul Asan Medical center

    Seoul

    Dok-Hyun Yoon, M.D Ph.D, +82 02-3010-5940, dhyoon@amc.seoul.kr

    Recruiting

  • Seoul Asan Medical center

    Seoul

    Jae-Lyun Lee, M.D Ph.D, +82-3010-5977, jaelyun@amc.seoul.kr

    Not yet recruiting

  • Seoul National University Hospital

    Seoul

    Youngil Koh, M.D Ph.D, +82 02-6072-5206, go01@snu.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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.

Read the 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.

Being tested
GIC-102
Medical subject headings
Lymphoma, Non-Hodgkin, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIC-102Drug

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

  • GIC-102Drug

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

Study groups in NCT05880043
Study groupRoleWhat they receive
Dose escalation phase: GIC-102 monotherapyExperimental* 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
Receives: Drug: GIC-102
Dose expansion phase: GIC-102 monotherapyExperimental- Dose level: RP2D
Receives: Drug: GIC-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity assessment (dose escalation phase)

    To determine the maximum tolerated dose of allogeneic natural killer cells

    Measured: Up to 4 weeks

  2. Adverse event / Immune related adverse event

    To determine the safety of GIC-102

    Measured: through study completion, an average of 1 year

  3. 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)

    Measured: through study completion, an average of 1 year

Secondary outcomes (8)

  1. 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)

    Measured: through study completion, an average of 1 year

  2. Progression free survival (PFS)

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

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

  3. Overall survival (OS)

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

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

  4. 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

    Measured: Through study completion

  5. Disease Control Rate (DCR)

    Percentage of patients who have achieved CR, PR and stable disease (SD)

    Measured: through study completion, an average of 1 year

  6. PK Profile (dose expansion phase) -Cmax

    Measured: up to 6 months

  7. PK Profile (dose expansion phase) - Tmax

    Measured: up to 6 months

  8. PK Profile (dose expansion phase) - AUC

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start28 Apr 2023
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Dose escalation phase: up to 30 subjects / Dose expansion phase: up to 20 subjects
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880043
Sponsor's protocol ID
GIC-102101
Status last verified
Jun 2024
First submitted
24 Apr 2023
Last updated
9 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GIC-102 in people with Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma, run by GI Cell, Inc. at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity assessment (dose escalation phase) (time frame: Up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.

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