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

Cutaneous T-cell Lymphoma (CTCL) Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05156229
Study type	Interventional
Source	Codiak BioSciences
Contact
Status	Terminated
Phase	Phase 1
Start date	September 6, 2021
Completion date	August 24, 2022

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See also
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