Cutaneous T Cell Lymphoma (CTCL)Early Phase 1CITYNCT07213882
A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)
A Early Phase 1 study testing DT-7012 in people with Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of lymphomas characterized by a primary involvement of the skin. Among them, mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes. SS is defined as erythroderma (erythema of the entire skin surface), and circulating tumor blood cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma (CTCL), Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- DT-7012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Adult Patients (≥18 years) with no upper age limit
- Confirmed diagnosis of mycosis fungoides or Sezary syndrome
- Stage IB to IVB in the ISCL / EORTC classification
- Relapsed or refractory (no response) after at least two systemic treatments
- ECOG performance status 0-1
- Adequate liver function:
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- Total bilirubin ≤ 1.5 xULN, or Direct bilirubin ≤ 1.5xULN if total bilirubin is >1.5xULN, or total bilirubin >1.5 xULN if elevated total bilirubin is attributed to Gilbert's syndrome or to histologically-proven liver involvement by CTCL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2,5 x ULN, unless elevated to up to 5 x ULN due to CTCL
- Adequate hematological function:
- Absolute neutrophil count of ≥ 1.5 G/L without G-CSF support for at least 7 days
- Platelet count of ≥ 75 G/L without platelet transfusion within 7 days
- Hemoglobin ≥ 9 g/dL without RBC transfusion within 7 days
- Adequate renal function: creatinine clearance calculated by Cockcroft \& Gault formula of ≥ 50 mL/min
- HBV: negative blood HBs Ag or blood HBV DNA. Vaccinated patients may be included. Patients with HBc antibody may be included if HBV DNA is negative
- HCV: negative HCV serology, or negative HCV RNA if HCV serology is positive
- HIV: negative HIV serology
- Negative serum or urinary pregnancy test within 7 days or at baseline prior to study treatment in women of childbearing potential
- Patients must agree to use a highly effective contraceptive method from inclusion until:
- If the patient is a male: at least 6 months after the last dose of DT-7012. Men must refrain from donating sperm during this same period
- If patient is a female of childbearing potential: at least 6 months after the last dose of DT-7012
- Patients must have the following minimum wash-out from previous treatments:
- 12 weeks for total skin electron beam irradiation,
- 4 weeks for monoclonal antibodies
- 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-neoplastic investigational agents
- 3 weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion proteins
- 3 weeks for phototherapy
- 2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or imiquimod). Topical steroids and oral steroids (10 mg prednisone equivalent/day maximum) are allowed, if the patient has been on a stable dose with stable symptoms for at least 4 weeks prior to study entry.
- Patient covered by any social security system (registered or being a beneficiary of such a scheme) for French participants only
- Signed informed consent
Who cannot join
- Known central nervous system involvement by CTCL
- Participation in any study of a health product within 30 days prior to study entry
- Patients with a history of other malignancies during the past three years (except for: non-melanoma skin cancer, lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ, which are not considered exclusion criteria).
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), or angina, myocardial infarction, cerebrovascular accident, transient ischemic attack within 6 months prior to study entry
- Any severe acute or chronic medical or psychiatric condition
- Patients with immunodeficiency
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- Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 1 week prior to first study drug dose
- Chronic use of systemic corticosteroids of prednisone or equivalent >10 mg prednisone equivalent/day for a chronic condition (washout of 8 days from start of treatment is accepted)
- Other immunosuppressive therapies are also excluded, (washout of 7 days from start of treatment is accepted)
- Autologous Hematopoietic Stem Cell Transplantation (HSCT) within 100 days prior to DT-7012 infusion
- Prior allogeneic HSCT
- Prior solid organ transplantation
- Patient with history of confirmed progressive multifocal leukoencephalopathy
- Known or suspected allergies, hypersensitivity, or intolerance to DT-7012 or its excipients
- Pregnant or breast-feeding woman, or desire (for both man and woman participant) to conceive a child within 6 months after end of treatment
- Patient under guardianship or curatorship and protected adults or unable to consent
- Coagulation disorder contra indicating intravenous infusion
- History of anaphylactic reaction following vaccination or immunotherapy
- History or current immune pneumonitis or interstitial lung disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of lymphomas characterized by a primary involvement of the skin. Among them, mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes. SS is defined as erythroderma (erythema of the entire skin surface), and circulating tumor blood cells. The circulating tumor T cells express CD4 and may lose expression of CD7 and CD26, while exhibiting in most cases aberrant expression of CD158k (KIR3DL2), which is a surface marker of Sézary cells. CCR8 is a surface marker of tumor-infiltrating regulatory T cells. It has recently be observed that CCR8 was expressed by tumor cells in CTCL and other peripheral T-cell lymphomas. CCR8 is expressed by skin resident-memory T cells which are believed to be the tumor cell-of-origin in mycosis fungoides. Domain Therapeutics (DT) showed the in vitro efficacy of their proprietary anti-CCR8 mAb DT7012 in the depletion of CTCL cells. Therapeutic depletion of CCR8-expressing cells by DT-7012 could eliminate tumor cells and activate the anti-tumor immunity in CTCL. We hypothesize that treatment with DT-7012 is effective in the treatment of relapsed or refractory (R/R) CTCL as advanced MF and SS.
- Being tested
- DT-7012
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT-7012Drug
This study use the Bayesian one-stage time-to-event continual reassessment method (TITE-CRM) design for dose finding phase I clinical trials, using an empirical dose-toxicity model with linear weights. A maximum total of 30 patients with CTCL, given 4 candidate dose levels (0.3; 1.0; 3.0; 10.0 mg/kg) will be dose-assigned starting from 1mg/kg dose level, in cohorts of 1 patient and including safety rules notably to ensure staggered accrual.
| Study group | Role | What they receive |
|---|---|---|
| single agent DT-7012 | Experimental | Not described Receives: Drug: DT-7012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) defined by any treatment-emergent adverse event (TEAE) not attributable to the disease or disease-related processes
Any Grade ≥ 3 non-hematologic toxicity lasting at least 7 days is considered
DLT, EXCEPT for:
- Isolated laboratory findings with no clinical signs or symptoms,
- Grade 3 fatigue, nausea, vomiting, diarrhea, or other manageable constitutional symptom that is responsive to supportive therapy and resolves to Grade ≤ 2 (or baseline if baseline is Grade ≥ 2) within 72 hours
Any Grade ≥ 3 hematologic toxicity is considered DLT, EXCEPT for:
- Grade 3 neutropenia (without fever and not requiring growth factor support) lasting for less than 7 days,
- Grade 3 thrombocytopenia without clinically significant bleeding or requiring platelet transfusion,
- Grade 3 leukopenia/lymphopenia,
- Grade 3 anemia that does not require transfusion.
Measured: Up to 12 months
Secondary outcomes (26)
Incidence of Adverse events
Adverse Events (AEs), Serious Adverse Events (SAEs), Drug related AEs, Drug related SAEs, Adverse Events of Special Interest (AESI)
Measured: Up to 12 months
Objective Response Rate
Measured: At 3 months
Complete Response (CR)
Measured: At 3 months
Partial Response (PR)
Measured: At 3 months
Maximum concentration (Cmax) of DT-7012
At each administration
Measured: Up to 12 months
Trough concentration (Cmin) of DT-7012
At each administration
Measured: Up to 12 months
Area under the curve (AUC₀-₇) for the first administration
from time 0 to day 7
Measured: Up to 12 months
Area under the curve (AUC₀-₇) for the fourth administration
from time 0 to day 7
Measured: Up to 12 months
Accumulation index (AI)
Expressed as the ratio of concentrations between the fourth and first administration
Measured: Up to 12 months
Accumulation index (AI)
Expressed as the ratio of AUC between the fourth and first administration
Measured: Up to 12 months
Presence of anti-drug antibodies
Measured: Up to 12 months
Presence of pruritus
Assessed by a visual analogue scale (VAS)
Measured: At 3 months
Presence of pruritus
Assessed by a visual analogue scale (VAS)
Measured: At 6 months
Presence of pruritus
Assessed by a visual analogue scale (VAS)
Measured: At 12 months
Health Related Quality of Life
By a standardized skin-specific questionnaire (SkinDex29). Total score varies from 0 to 100. The higher the score the lower the quality of life
Measured: At 3 months
Health Related Quality of Life
By a standardized skin-specific questionnaire (SkinDex29). Total score varies from 0 to 100. The higher the score the lower the quality of life
Measured: At 6 months
Health Related Quality of Life
By a standardized skin-specific questionnaire (SkinDex29). Total score varies from 0 to 100. The higher the score the lower the quality of life
Measured: At 12 months
Health Related Quality of Life
By the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30). Total score varies from 0 to 100. The higher the score the lower the quality of life.
Measured: At 3 months
Health Related Quality of Life
By the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30). Total score varies from 0 to 100. The higher the score the lower the quality of life.
Measured: At 6 months
Health Related Quality of Life
By the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30). Total score varies from 0 to 100. The higher the score the lower the quality of life.
Measured: At 12 months
Time to next treatment (TTNT)
Time from initiation of DT-7012 until the time of initiation of any systemic treatment or total-skin treatment (phototherapy or TSEB).
Measured: Up to 12 months
Disease control rate
Defined as complete, partial response or stable disease
Measured: At 3 months
Disease control rate
Defined as complete, partial response or stable disease
Measured: At 6 months
Disease control rate
Defined as complete, partial response or stable disease
Measured: At 12 months
Duration of response (DoR)
Time from measurement of CR/PR (whichever is first recorded) until the date of documented recurrent or progressive disease, assessed in responder patients only
Measured: Up to 12 months
Progression-Free-Survival
Defined with the time from the first DT-7012 administration to progressive disease, relapse, death, or last follow-up.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label, multicenter prospective phase 1 dose-escalation study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Domain Therapeutics SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213882
- Sponsor's protocol ID
- APHP240605
- Acronym
- CITY
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)
- ClinicalTrials.gov ID
- NCT07213882
- Acronym / sponsor ID
- CITY / APHP240605
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Domain Therapeutics SA
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 9 Oct 2025 (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.
Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of lymphomas characterized by a primary involvement of the skin. Among them, mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes. SS is defined as erythroderma (erythema of the entire skin surface), and circulating tumor blood cells. The circulating tumor T cells express CD4 and may lose expression of CD7 and CD26, while exhibiting in most cases aberrant expression of CD158k (KIR3DL2), which is a surface marker of Sézary cells. CCR8 is a surface marker of tumor-infiltrating regulatory T cells. It has recently be observed that CCR8 was expressed by tumor cells in CTCL and other peripheral T-cell lymphomas. CCR8 is expressed by skin resident-memory T cells which are believed to be the tumor cell-of-origin in mycosis fungoides. Domain Therapeutics (DT) showed the in vitro efficacy of their proprietary anti-CCR8 mAb DT7012 in the depletion of CTCL cells. Therapeutic depletion of CCR8-expressing cells by DT-7012 could eliminate tumor cells and activate the anti-tumor immunity in CTCL. We hypothesize that treatment with DT-7012 is effective in the treatment of relapsed or refractory (R/R) CTCL as advanced MF and SS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label, multicenter prospective phase 1 dose-escalation study
| Arm | Type | Receives |
|---|---|---|
| single agent DT-7012 | Experimental | Drug: DT-7012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Adult Patients (≥18 years) with no upper age limit
- Confirmed diagnosis of mycosis fungoides or Sezary syndrome
- Stage IB to IVB in the ISCL / EORTC classification
- Relapsed or refractory (no response) after at least two systemic treatments
- ECOG performance status 0-1
Key exclusion criteria (19 listed)
- Known central nervous system involvement by CTCL
- Participation in any study of a health product within 30 days prior to study entry
- Patients with a history of other malignancies during the past three years (except for: non-melanoma skin cancer, lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ, which are not considered exclusion criteria).
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), or angina, myocardial infarction, cerebrovascular accident, transient ischemic attack within 6 months prior to study entry
- Any severe acute or chronic medical or psychiatric condition
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 |
|---|---|---|
| DT-7012This study use the Bayesian one-stage time-to-event continual reassessment method (TITE-CRM) design for dose finding phase I clinical trials, using an empirical dose-toxicity model with linear weights. A maximum total of 30 patients with CTCL, given 4 candidate dose levels (0.3; 1.0; 3.0; 10.0 mg/kg) will be dose-assigned starting from 1mg/kg dose level, in cohorts of 1 patient and including safety rules notably to ensure staggered accrual. | Drug | single agent DT-7012 |
Primary outcome
Dose limiting toxicity (DLT) defined by any treatment-emergent adverse event (TEAE) not attributable to the disease or disease-related processes
Time frame: Up to 12 months
Any Grade ≥ 3 non-hematologic toxicity lasting at least 7 days is considered DLT, EXCEPT for: * Isolated laboratory findings with no clinical signs or symptoms, * Grade 3 fatigue, nausea, vomiting, diarrhea, or other manageable constitutional symptom that is responsive to supportive therapy and resolves to Grade ≤ 2 (or baseline if baseline is Grade ≥ 2) within 72 hours Any Grade ≥ 3 hematologic toxicity is considered DLT, EXCEPT for: * Grade 3 neutropenia (without fever and not requiring growth factor support) lasting for less than 7 days, * Grade 3 thrombocytopenia without clinically significant bleeding or requiring platelet transfusion, * Grade 3 leukopenia/lymphopenia, * Grade 3 anemia that does not require transfusion.
26 secondary outcomes
Incidence of Adverse events
Time frame: Up to 12 months
Objective Response Rate
Time frame: At 3 months
Complete Response (CR)
Time frame: At 3 months
Partial Response (PR)
Time frame: At 3 months
Maximum concentration (Cmax) of DT-7012
Time frame: Up to 12 months
Trough concentration (Cmin) of DT-7012
Time frame: Up to 12 months
Area under the curve (AUC₀-₇) for the first administration
Time frame: Up to 12 months
Area under the curve (AUC₀-₇) for the fourth administration
Time frame: Up to 12 months
Accumulation index (AI)
Time frame: Up to 12 months
Accumulation index (AI)
Time frame: Up to 12 months
Presence of anti-drug antibodies
Time frame: Up to 12 months
Presence of pruritus
Time frame: At 3 months
Presence of pruritus
Time frame: At 6 months
Presence of pruritus
Time frame: At 12 months
Health Related Quality of Life
Time frame: At 3 months
Health Related Quality of Life
Time frame: At 6 months
Health Related Quality of Life
Time frame: At 12 months
Health Related Quality of Life
Time frame: At 3 months
Health Related Quality of Life
Time frame: At 6 months
Health Related Quality of Life
Time frame: At 12 months
Time to next treatment (TTNT)
Time frame: Up to 12 months
Disease control rate
Time frame: At 3 months
Disease control rate
Time frame: At 6 months
Disease control rate
Time frame: At 12 months
Duration of response (DoR)
Time frame: Up to 12 months
Progression-Free-Survival
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DT-7012 in people with Cutaneous T Cell Lymphoma (CTCL) and Mycosis Fungoides, run by Assistance Publique - Hôpitaux de Paris.
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 29 inclusion and 19 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: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline RAM WOLFF, MD (+33142499961 ext. +33, caroline.ram-wolff@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) defined by any treatment-emergent adverse event (TEAE) not attributable to the disease or disease-related processes (time frame: Up to 12 months). 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 9 Oct 2025.