Clinical trial · Interventional
Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R 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
NCT06699771CI-TRIAL-00119270recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, T-Cell | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| GCC2005 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1a Dose-Escalation and Phase 1b Dose and Regimen Optimization and Exploratory Expansion
- description
- Phase 1a Multiple-Dose Cohort and Phase 1b Single-Dose Cohort
- interventionNames
- Drug: GCC2005
- Drug: Cyclophosphamide
- Drug: Fludarabine
Primary outcomes (2)
- measure
- Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher
- timeFrame
- From the time of enrollment through End of Study (up to 18 months per patient)
- description
- To evaluate the safety and tolerability of GCC2005 in patients with relapsed/refractory NK/T cell malignancies. Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.