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Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies

RecruitingPhase 1Ages 19 Years - 80 YearsAllGC Cell Corporation
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 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.
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What it tests

  • GCC2005
  • Cyclophosphamide
  • Fludarabine
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Where

3 sites
Seoul National University Hosptial
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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