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

Launched by GC CELL CORPORATION · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GCC2005 for patients with specific types of cancer known as T-cell and NK-cell malignancies. These are cancers that can be difficult to treat, especially if they have not responded to previous therapies. The trial aims to determine if GCC2005 is safe and how well it works for people who have already undergone at least two other treatments without success.

To be eligible for this trial, participants must have a certain type of cancer that has come back or has not improved with prior treatments. They should also have measurable tumors, meaning the cancer can be seen and measured through medical imaging. Participants should be between 18 and 75 years old and generally in decent health, as determined by a doctor. During the trial, participants will receive the study treatment and be closely monitored for any side effects or changes in their condition. It’s important to know that this trial is not yet recruiting patients, so there will be more information available in the future for those interested.

Gender

ALL

Eligibility 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.