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)

Codiak BioSciences4 sites in 1 country2 target enrollmentSeptember 6, 2021

ConditionsCutaneous T-cell Lymphoma (CTCL)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cutaneous T-cell Lymphoma (CTCL)
Sponsor: Codiak BioSciences
Enrollment: 2
Locations: 4
Primary Endpoint: Primary Outcome
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 6, 2021

End Date

August 24, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Codiak BioSciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed CTCL as per Olsen et al, 2011 or per algorithm for diagnosis of early MF as per Pimpinelli et al,
•Patient-participants with Stage IA-IIB CTCL (MF) with injectable lesions (patches, plaques, or tumors), who have relapsed or refractory disease following at least 1 prior standard treatment. Patient-participants who are unsuitable to receive standard treatment or who have declined standard treatment are also eligible.
•Patient-participants must have ≥ 1 treatable/measurable lesion(s) for injection as per Olsen criteria.
•Understands and is able to comply with the study requirements and has signed the informed consent form.
•Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
•Life expectancy of at least 6 months.
•Age 18 years or older at the time of signing the informed consent form.
•Acceptable liver function:
•Bilirubin equal 1.5x ULN.
•AST (SGOT), ALT (SGPT) equal 3.0x ULN.

Exclusion Criteria

•Patient-participants with CTCL disease involving N3 nodes.
•Clinically significant ongoing AEs that have not returned to baseline or to Grade 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 during the Screening Period.
•Received nitrogen mustard, PUVA, narrow band UVB light therapy, carmustine (BCNU), other systemic therapies, radiation therapy or investigational agents for CTCL within 21 days of Day
•Received systemic corticosteroids within 28 days of Day
•Use of topical corticosteroids on any of the target lesions for CDK-003 injection or non-injected target lesion within 28 days of Day
•Topical corticosteroid use is permitted for non-target lesions.
•Major surgery within 2 months or minor surgery (excluding tumor biopsies) within 14 day prior to Day
•Clinically significant cardiovascular disease including but not limited to myocardial infarction or stroke within the past 6 months prior to Day 1, New York Heart Association Class III or IV heart failure, uncontrolled arrhythmia, or severe aortic stenosis. Sponsor approval of patient-participants with an arrhythmia is required.
•Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
•Prophylactic antibiotics are acceptable.