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

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.

Eligibility

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.

Conditions2

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