Cutaneous T-cell Lymphoma (CTCL)Phase 1Part BNCT05156229
A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL).
A Phase 1 study testing CDK-003 in people with Cutaneous T-cell Lymphoma (CTCL), run by Codiak BioSciences at 4 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-cell Lymphoma (CTCL)
- What is being tested?
- CDK-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 6 Sep 2021to 24 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- Serum creatinine ≤ 1.5x ULN.
- Acceptable hematologic status:
- Absolute neutrophil count - 1500 cells/mm3
- Platelet count - 100,000 /mm3
- Hemoglobin - 9 g/dL.
- Acceptable coagulation status: international normalized ratio ≤ 1.5 ULN. Patient-participants on therapeutic doses of vitamin K antagonists (eg, warfarin) or direct oral anticoagulants (eg, direct thrombin or direct factor Xa inhibitors) are not eligible.
- Anticoagulation with low molecular weight heparins is permitted.
- Women of child-producing potential agree to use highly effective contraceptive methods (see Appendix C for details) for one complete menstrual cycle (or at least 30 days) prior to the first dose of CDK-003 until 6 months following the last dose of CDK-003, and avoid egg donation from the time of the first dose of CDK-003 until 6 months following the last dose of CDK-003. A female participant is considered to be of child-producing potential unless she:
- has had a hysterectomy or bilateral oophorectomy or
- is age ≥ 60 years and is amenorrhoeic or
- is age < 60 years and has been amenorrhoeic for ≥ 12 months (including no irregular menses or spotting) in the absence of any medication which induces a menopausal state and has documented ovarian failure by serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range).
- A negative pregnancy test (if a woman of child-producing potential) within 72 hours prior to the first dose of CDK-003.
- Men of child-producing potential agree to use highly effective contraceptive methods and avoid sperm donation from the time of the first dose of CDK-003 until 6 months following the last dose. Male patient-participants must use a condom when engaged in intercourse during the study and for 6 months after the last dose of study drug.
- A man is considered to be of child-producing potential unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy.
- Patient-participant agrees to have a pre-treatment tumor biopsy during the Screening Period, and 2 on-treatment tumor biopsies of the same lesion.
Who cannot join
- 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.
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- 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.
- History of another malignancy, unless potentially curative treatment has been performed. Sponsor approval is required. Patient-participants with early stage prostate cancer on active surveillance may be enrolled with Sponsor approval.
- Currently receiving any other anti-cancer or investigational agent.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
University Hospital Birmingham
Birmingham, B15 2TH
Beatson West of Scotland Cancer Centre Haematology
Glasgow, G12 0YN
Guys Hospital/ Guy's Cancer Centre
London, SE1 9RT
The Christie
Manchester, M20 4BX
About this study
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)
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)
- Being tested
- CDK-003
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK-003Biological
CDK-003 administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| CDK-003 | Experimental | CDK-003 administered subcutaneously every 2 weeks. Receives: Biological: CDK-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
To determine the safety, tolerability, and DLTs of CDK-003 monotherapy following multiple ascending dose escalation in patient-participants with CTCL
Measured: up to 2 years
Primary Outcome
To identify a recommended phase 2 dose (RP2D) for CDK-003 monotherapy.
Measured: up to 2 years
Secondary outcomes (1)
Secondary Outcome
To evaluate the preliminary anti-tumor activity of CDK-003 monotherapy
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start6 Sep 2021
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Why it stopped: PK/PD from two patients plus the healthy volunteer data confirmed the RP2D and manageable safety profile. Proceeding to Phase II did not require additional data from this Phase I Dose-Finding study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell Lymphoma (CTCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codiak BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Scarisbrick, MD, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156229
- Sponsor's protocol ID
- CDK-003-101
- Acronym
- Part B
- Status last verified
- Aug 2022
- First submitted
- 1 Dec 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05156229
- Acronym / sponsor ID
- Part B / CDK-003-101
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PK/PD from two patients plus the healthy volunteer data confirmed the RP2D and manageable safety profile. Proceeding to Phase II did not require additional data from this Phase I Dose-Finding study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Codiak BioSciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDK-003 | Experimental | Biological: CDK-003CDK-003 administered subcutaneously every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDK-003CDK-003 administered subcutaneously | Biological | CDK-003 |
Primary outcome
Primary Outcome
Time frame: up to 2 years
To determine the safety, tolerability, and DLTs of CDK-003 monotherapy following multiple ascending dose escalation in patient-participants with CTCL
Primary Outcome
Time frame: up to 2 years
To identify a recommended phase 2 dose (RP2D) for CDK-003 monotherapy.
1 secondary outcome
Secondary Outcome
Time frame: up to 2 years
Results and safety
The study was stopped early (reason given: PK/PD from two patients plus the healthy volunteer data confirmed the RP2D and manageable safety profile. Proceeding to Phase II did not require additional data from this Phase I Dose-Finding study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Scarisbrick, MD principal investigator
University Hospital Birmingham NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDK-003 in people with Cutaneous T-cell Lymphoma (CTCL), run by Codiak BioSciences at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PK/PD from two patients plus the healthy volunteer data confirmed the RP2D and manageable safety profile. Proceeding to Phase II did not require additional data from this Phase I Dose-Finding study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.