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

NCT05156229 | Terminated Phase 1 FDA Drug

• 1 other identifier: CDK-003-101
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

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.

Conditions

Cutaneous T-cell Lymphoma (CTCL)

Outcome Measures

Primary Outcomes (2)

• Primary Outcome

  To determine the safety, tolerability, and DLTs of CDK-003 monotherapy following multiple ascending dose escalation in patient-participants with CTCL

  up to 2 years

• Primary Outcome

  To identify a recommended phase 2 dose (RP2D) for CDK-003 monotherapy.

  up to 2 years

Secondary Outcomes (1)

• Secondary Outcome

  up to 2 years

Other Outcomes (1)

• Exploratory Outcome

  up to 2 years

Study Arms (1)

CDK-003

EXPERIMENTAL

CDK-003 administered subcutaneously every 2 weeks.

Biological: CDK-003

Interventions

CDK-003 BIOLOGICAL

CDK-003 administered subcutaneously

CDK-003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed CTCL as per Olsen et al, 2011 or per algorithm for diagnosis of early MF as per Pimpinelli et al, 2005.
• 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 1.
• 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.
• Acceptable renal function:
• a. Serum creatinine ≤ 1.5x ULN.
• Acceptable hematologic status:
• Absolute neutrophil count - 1500 cells/mm3
• Platelet count - 100,000 /mm3

You may not qualify if:

• 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 1.
• Received systemic corticosteroids within 28 days of Day 1.
• Use of topical corticosteroids on any of the target lesions for CDK-003 injection or non-injected target lesion within 28 days of Day 1. 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 1.
• 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.
• Prior organ or stem cell transplant.
• Primary immune deficiency.
• Pregnant or nursing women.
• Positive test for HBsAg, HCV Ab, or HIV Ab during the Screening Period.
• Unwillingness or inability to comply with procedures required in this protocol.
• Serious non-malignant disease (e.g., liver failure, ongoing infection requiring intravenous treatment, psychological illness, autoimmune disease including but not limited to inflammatory bowel disease, or other conditions) or social situations that, in the opinion of the Investigator and/or the Sponsor, could compromise protocol objectives or patient participant safety or the ability of the patient-participant to comply with the protocol.

Sponsors & Collaborators

• Codiak BioSciences: lead

Study Sites (4)

University Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Beatson West of Scotland Cancer Centre Haematology

Glasgow, G12 0YN, United Kingdom

Location

Guys Hospital/ Guy's Cancer Centre

London, SE1 9RT, United Kingdom

Location

The Christie

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Julia Scarisbrick, MD

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: September 6, 2021
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)