Safety, Tolerability, PK and PD of CDK-003 in HV and patients
Research type
Research Study
Full title
A Phase 1, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered CDK 003 in Healthy Adult Participants and Intralesionally Administered CDK 003 in Patient-participants with Cutaneous T-cell Lymphoma (CTCL)
IRAS ID
284162
Contact name
Julia Scarisbrick
Contact email
Sponsor organisation
Codiak Biosciences Inc
Eudract number
2020-001978-29
Duration of Study in the UK
0 years, 5 months, 26 days
Research summary
We are conducting a clinical trial for a new drug called CDK-003 which has been developed to help control the symptoms of a cancer called Cutaneous T- cell lymphoma (CTCL). This is a cancer of the body’s immune cells that causes them predominantly to attack the skin.\nCDK-003 is an exosome (small bleb of cellular tissue) which displays single chain interleukin 12 (IL-12, a pro-inflammatory molecule) on its surface. IL-12 promotes the activation of the bodies immune system to help it to better fight the cancerous cells. Previous trials have shown IL-12 is successful in improving or in some cases clearing tumours, but that when given systemically, it has very significant toxic side effects. CDK-003 is designed to be given into a small area and not to spread into the rest of the body, limiting its effect to the area requiring treatment.\nThe purpose of Part A of this study is to assess how the body processes and reacts to CDK-003 and how safe and well tolerated it is in healthy volunteers when administered subcutaneously (just under the skin), avoiding systemic exposure. \nWe propose to recruit up to 25 volunteers in five cohorts. Each cohort will randomly assign 3 people to active drug and 2 to placebo. \nPart B of this study will assess CDK-003 in patients with CTCL but will be conducted at different trial sites.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0215
Date of REC Opinion
3 Aug 2020
REC opinion
Further Information Favourable Opinion