CDK-003-101
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
290972
Contact name
Wendy Hill
Contact email
Sponsor organisation
Codiak BioSciences, Inc.
Eudract number
2020-001978-29
ISRCTN Number
NCT05156229
Duration of Study in the UK
1 years, 6 months, 1 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 cancer called Cutaneous T- cell lymphoma (CTCL). This is a cancer of the body’s immune cells that causes them to initially attack the skin.
CDK-003 is an exosome (a small 'bleb' of cellular tissue) which displays single chain interleukin 12 (IL-12, a pro-inflammatory molecule) on its surface. IL-12 promotes activation of the body's immune system to help it fight cancer cells. Previous trials have shown IL-12 is successful in improving or in some cases clearing tumours. However, when given intravenously, it has significant side effects. CDK-003 is designed to be injected into
the CTCL lesion or tumour and not to spread into the rest of the body, to try to get the benefits without the side-effects.Part B of the study will enrol subjects with Stage IA – IIB CTCL (called Mycosis Fungoides) and will determine the safety, tolerability, and dose-limiting toxicities (DLTs) of CDK-003 given alone following multiple ascending dose escalation, in a single-arm, open-label study design, to identify a recommended phase 2 dose (RP2D) for CDK-003 monotherapy.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0001
Date of REC Opinion
15 Jan 2021
REC opinion
Favourable Opinion