Lymphoma, T-CellPhase 1NCT06699771
Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies
A Phase 1 study testing GCC2005, Cyclophosphamide and Fludarabine in people with Lymphoma, T-Cell, run by GC Cell Corporation at 3 sites in South Korea.
Trial summary
This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Lymphoma, T-Cell
- What is being tested?
- GCC2005, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 7 Mar 2025to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
- Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.
- According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.
- Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Participants who satisfy the criteria defined in the protocol.
- Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants who comply with all procedures of this study and voluntarily give written consent
Who cannot join
- Has T-ALL/T-LBL, CTCL or ALCL.
- Participants with CNS lymphoma or any involvement of the CNS.
- Participants who had a prior history of another malignancy over the last 3 years.
- Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
- Participants who have had prior CAR-T or CAR-NK therapies.
- Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management
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- Participants with previous allogenic organ transplantation
- Participants with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.
- Participants with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.
- Participants with known active Hepatitis B or C
- Participants with presence of Grade 2 or greater toxicity from the previous treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hosptial
Seoul, Seoul, 03080
Youngil Koh, MD, +82-2-2072-7217, go01@snu.ac.kr
Youngil Koh, MD
- Recruiting
Asan Medical Center
Seoul, Seoul, 05505
DokHyun Yoon, MD, +82-2-3010-5940, dhyoon@amc.seoul.kr
DokHyun Yoon, MD
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Won Seog Kim, MD, +82-2-2148-7390, wonseog.kim@samsung.com
Won Seog Kim, MD
About this study
Official title: A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies
This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy.
Read the detailed description
The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of GCC2005 in treatment of patients with relapsed or refractory NK cell and T-cell malignancies expressing CD5. Phase 1a of the study will be conducted to establish a dose range that is well tolerated by the majority of participants and to determine a safety profile of GCC2005 in participant population. Phase 1b of this study is planned to evaluate safety, PK/PD characteristics, and preliminary efficacy following single administration, reflecting the cumulative exposure level obtained with multiple administration based on the safety and tolerability assessment results confirmed in Phase 1a, and to assess dose and regimen optimization to determine the RP2D for subsequent studies.
- Conditions
- Lymphoma, T-Cell
- Being tested
- GCC2005, Cyclophosphamide, Fludarabine
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCC2005Drug
CAR-NK Cell Therapy
CyclophosphamideDrug
Lymphodepleting chemotherapy
FludarabineDrug
Lymphodepleting chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose-Escalation and Phase 1b Dose and Regimen Optimization and Exploratory Expansion | Experimental | Phase 1a Multiple-Dose Cohort and Phase 1b Single-Dose Cohort Receives: Drug: GCC2005; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher
To evaluate the safety and tolerability of GCC2005 in patients with relapsed/refractory NK/T cell malignancies.
Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs.
Dose-limiting toxicities (DLTs)
Measured: From the time of enrollment through End of Study (up to 18 months per patient)
To determine MTD and RP2D: Safety(based on frequency, severity, and persistence of AEs and AEs Grade 3 or higher), efficacy (based on ORR) and pharmacokinetics
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs.
Dose-limiting toxicities (DLTs)
Measured: From the time of enrollment through End of Study (up to 18 months per patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start7 Mar 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The dose-escalation part of the study (Phase 1a) employs a 3+3 design to determine the DLT of GCC2005. The dose and regimen optimization and exploratory expansion part (Phase 1b) uses a 3+3 design with optional backfill enrollment to determine MTD and RP2D.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Cell Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artiva Biotherapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699771
- Sponsor's protocol ID
- GCC2005A-P101
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies
- ClinicalTrials.gov ID
- NCT06699771
- Acronym / sponsor ID
- GCC2005A-P101
- Conditions
- Lymphoma, T-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- GC Cell CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Artiva Biotherapeutics, Inc.
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy.
Detailed description
The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of GCC2005 in treatment of patients with relapsed or refractory NK cell and T-cell malignancies expressing CD5. Phase 1a of the study will be conducted to establish a dose range that is well tolerated by the majority of participants and to determine a safety profile of GCC2005 in participant population. Phase 1b of this study is planned to evaluate safety, PK/PD characteristics, and preliminary efficacy following single administration, reflecting the cumulative exposure level obtained with multiple administration based on the safety and tolerability assessment results confirmed in Phase 1a, and to assess dose and regimen optimization to determine the RP2D for subsequent studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The dose-escalation part of the study (Phase 1a) employs a 3+3 design to determine the DLT of GCC2005. The dose and regimen optimization and exploratory expansion part (Phase 1b) uses a 3+3 design with optional backfill enrollment to determine MTD and RP2D.
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose-Escalation and Phase 1b Dose and Regimen Optimization and Exploratory Expansion | Experimental | Drug: GCC2005, Drug: Cyclophosphamide, Drug: FludarabinePhase 1a Multiple-Dose Cohort and Phase 1b Single-Dose Cohort |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
- Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.
- According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.
- Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Participants who satisfy the criteria defined in the protocol.
Key exclusion criteria (11 listed)
- Has T-ALL/T-LBL, CTCL or ALCL.
- Participants with CNS lymphoma or any involvement of the CNS.
- Participants who had a prior history of another malignancy over the last 3 years.
- Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
- Participants who have had prior CAR-T or CAR-NK therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCC2005CAR-NK Cell Therapy | Drug | Phase 1a Dose-Escalation and Phase 1b Dose and Regimen Optimization and Exploratory Expansion |
| CyclophosphamideLymphodepleting chemotherapy | Drug | Phase 1a Dose-Escalation and Phase 1b Dose and Regimen Optimization and Exploratory Expansion |
| FludarabineLymphodepleting chemotherapy | Drug | Phase 1a Dose-Escalation and Phase 1b Dose and Regimen Optimization and Exploratory Expansion |
Primary outcome
Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher
Time frame: From the time of enrollment through End of Study (up to 18 months per patient)
To evaluate the safety and tolerability of GCC2005 in patients with relapsed/refractory NK/T cell malignancies. Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
To determine MTD and RP2D: Safety(based on frequency, severity, and persistence of AEs and AEs Grade 3 or higher), efficacy (based on ORR) and pharmacokinetics
Time frame: From the time of enrollment through End of Study (up to 18 months per patient)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GCC2005, Cyclophosphamide and Fludarabine in people with Lymphoma, T-Cell, run by GC Cell Corporation at 3 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 11 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HyeSung Jeon (+82-31-260-9059, hs_jeon@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher (time frame: From the time of enrollment through End of Study (up to 18 months per patient)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.