Investigating GCC2005 for patients with relapsed/refractory NK and T-cell malignancies
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 study is testing a new treatment called GCC2005 to see if it is safe and effective for people with certain types of blood cancers that have not responded to previous therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | GC Cell Corporation Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 3 sites (Seoul and 2 other locations) |
| Trial ID | NCT06699771 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with relapsed or refractory CD5+ NK and T-cell malignancies who have received at least two prior lines of therapy.
Not a fit: Patients with T-ALL/T-LBL, CTCL, or CNS involvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat NK and T-cell malignancies.
How similar studies have performed: While this approach is novel for GCC2005, similar studies targeting NK and T-cell malignancies have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017). * Patients 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, patients 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. * Patient has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status. * Patients 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. Exclusion Criteria: * Has T-ALL/T-LBL or CTCL. * Patient with CNS lymphoma or any involvement of the CNS. * Patient who had a prior history of another malignancy over the last 3 years. * Patients who have used hematopoietic growth factor therapy within 14 days prior to Screening. * Patients 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 * Patients with previous allogenic organ transplantation * Patients with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency. * Patients with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion. * Patients with known active Hepatitis B or C * Patients with presence of Grade 2 or greater toxicity from the previous treatment.
Where this trial is running
Seoul and 2 other locations
- Seoul National University Hosptial — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: HyeSung Jeon
- Email: hs_jeon@gccorp.com
- Phone: +82-31-260-9059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.