NCT05156229

A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL).

A Phase 1/2a Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CDK-003 in Healthy Adult Participants and Intralesionally Administered CDK-003 in Patients With Cutaneous T-cell Lymphoma (CTCL)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Codiak BioSciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, dose escalation study to assess the safety, tolerability, pharmacokinetic and pharmacodynamic effects of CDK-003. The study is performed in two parts: Part A is a randomized, double-blind, placebo-controlled, single ascending dose study of CDK-003 in healthy adult male participants, and Part B is a single arm, open-label, multiple ascending dose in patient-participants with CTCL. Dose escalation in the study will only occur after satisfactory review of all available predefined data by the Safety Review Committee. Part A is complete and this entry describes Part B only.

Conditions

• Cutaneous T-cell Lymphoma (CTCL)

Interventions

Type	Name	Description
BIOLOGICAL	CDK-003	CDK-003 administered subcutaneously

Timeline

• Start date: 2021-09-06
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2021-12-14
• Last updated: 2022-09-02

Locations

4 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study