Investigating GCC2005 for patients with relapsed/refractory NK and T-cell malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of GCC2005 in patients with relapsed or refractory NK and T-cell malignancies that express CD5. The study is divided into two parts: Phase 1a focuses on establishing a well-tolerated dose range and safety profile, while Phase 1b aims to optimize the dose to determine the maximum tolerated dose and recommended Phase 2 dose. Participants must have previously undergone at least two lines of therapy and have measurable disease as defined by specific criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Where it's running

• Seoul National University Hosptial
  Seoul, Seoul, South Korea Recruiting
• Asan Medical Center
  Seoul, Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: HyeSung Jeon
• Email: hs_jeon@gccorp.com
• Phone: +82-31-260-9059

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.