170 Participants Needed

IPH4102 for Cutaneous T-Cell Lymphoma

(TELLOMAK Trial)

Recruiting at 60 trial locations
IP
Overseen ByInnate Pharma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.

Will I have to stop taking my current medications?

The trial requires a minimum washout period (time without taking certain medications) of 3 weeks between the last dose of your previous systemic therapy and the first dose of IPH4102. This means you will need to stop taking your current systemic medications for at least 3 weeks before starting the trial treatment.

Is IPH4102 safe for humans?

IPH4102 has been tested in early clinical trials for cutaneous T-cell lymphoma and was found to be well-tolerated, suggesting it is generally safe for humans.12345

What data supports the effectiveness of the drug IPH4102 for treating cutaneous T-cell lymphoma?

The research highlights the need for new treatments for cutaneous T-cell lymphoma (CTCL) due to the high relapse rates and lack of curative therapies. Recent advances in understanding the disease's biology have led to the development of new systemic drugs and treatment strategies, suggesting that innovative approaches like IPH4102 could potentially be effective.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced T Cell Lymphoma, specifically Sezary Syndrome and Mycosis fungoides, who have tried at least two other treatments. They must be in good enough health to undergo a biopsy, not have had certain recent treatments or vaccines, no major surgery within the last month, and no active severe infections or other cancers in the past five years.

Inclusion Criteria

MF patients (Cohorts 2 and All comers): Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF; Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC; Patients should have received at least two prior systemic therapies; Feasibility of obtaining at least one skin biopsy at screening;
I have stage IVA or IVB SS, received at least two treatments, had mogamulizumab, and can have a skin biopsy.
Adequate baseline laboratory data: Hematology: Hemoglobin >9 g/dL, Absolute neutrophil count (ANC) ≥1,500/µL, Platelets ≥100,000/µL, Biochemistry: Bilirubin ≤1.5 X upper limit of normal (ULN) or ≤3 X ULN for patients with Gilbert's disease, Serum creatinine ≤1.5 X ULN, Creatinine clearance ≥30 mL/min, calculated with the Cockcroft & Gault formula, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 X ULN; Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12 months and capable to become pregnant. They must have a negative serum beta-HCG pregnancy test result within seven days from start of treatment; Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug; Signed informed consent form prior to any protocol-specific procedures

Exclusion Criteria

Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening; Receipt of live vaccines within 4 weeks prior to treatment; Central nervous system (CNS) lymphoma involvement; Prior administration of IPH4102; Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study; Autologous stem cell transplantation less than 3 months prior to enrollment; Prior allogenic transplantation; Patients who have undergone major surgery ≤ 4 weeks prior to study entry; Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection; Patients who have Hepatitis B Virus infection determined as HBsAg positive and / or Hepatitis C Virus infection determined as detection of HCV RNA in serum or plasma by a sensitive quantitative molecular method; Known or tested positive for human immunodeficiency virus (HIV); Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ; Pregnant or breastfeeding women; Known clinically significant cardiovascular disease or condition, including: Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification; Any uncontrolled arrhythmia (per the investigator's discretion); Uncontrolled hypertension (per the investigator's discretion). Patients with autoimmune disease on systemic immunosuppressive treatment; Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol; Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

IPH4102 is administered every week for 5 weeks, then every 2 weeks for 10 administrations, and then every 4 weeks until disease progression or unacceptable toxicity

Expected average of 2 years
Weekly visits initially, then bi-weekly, and finally monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IPH4102
Trial Overview The study tests IPH4102 alone or combined with chemotherapy on patients with T Cell Lymphoma. It's an open-label phase II trial which means everyone knows what treatment they're getting and it's designed to measure how well the drug works and its safety.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressingExperimental Treatment1 Intervention
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Group II: Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed)Experimental Treatment1 Intervention
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Group III: Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressingExperimental Treatment1 Intervention
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Group IV: Cohort 1: Relapsed/refractory Sezary SyndromeExperimental Treatment1 Intervention
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Innate Pharma

Lead Sponsor

Trials
29
Recruited
3,100+

Published Research Related to This Trial

Cutaneous T-cell lymphomas, including mycosis fungoides and Sezary syndrome, have distinct clinical behaviors, with mycosis fungoides being more indolent and Sezary syndrome being more aggressive, highlighting the need for tailored treatment approaches.
Current treatments include a variety of skin-directed and systemic therapies, but over 20% of patients with early-stage disease experience progression, indicating a significant need for more effective and durable treatment options, especially for advanced stages.
Efficacy and tolerability of currently available therapies for the mycosis fungoides and Sezary syndrome variants of cutaneous T-cell lymphoma.Whittaker, SJ., Foss, FM.[2007]
Cutaneous T-cell lymphomas (CTCL) have high relapse rates, but survival is generally not significantly affected in low-stage disease, while aggressive subtypes show reduced survival rates.
Recent research has identified new treatment strategies targeting tumor-infiltrating immune cells and the tumor microenvironment, focusing on restoring immunosurveillance and utilizing novel approaches like NF-κB or JAK inhibition.
Innovative Treatment Concepts for Cutaneous T-Cell Lymphoma Based on Microenvironment Modulation.Leuchte, K., Schlaak, M., Stadler, R., et al.[2018]

Citations

Molecular staging of lymph nodes from 60 patients with mycosis fungoides and Sézary syndrome: correlation with histopathology and outcome suggests prognostic relevance in mycosis fungoides. [2015]
Efficacy and tolerability of currently available therapies for the mycosis fungoides and Sezary syndrome variants of cutaneous T-cell lymphoma. [2007]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Novel systemic drugs for cutaneous T-cell lymphoma. [2019]
Optimal combination with PUVA: rationale and clinical trial update. [2018]
Innovative Treatment Concepts for Cutaneous T-Cell Lymphoma Based on Microenvironment Modulation. [2018]
IPH4102, a monoclonal antibody directed against the immune receptor molecule KIR3DL2, for the treatment of cutaneous T-cell lymphoma. [2018]
Phase II evaluation of VDC-1101 in canine cutaneous T-cell lymphoma. [2021]
IPH4102, a first-in-class anti-KIR3DL2 monoclonal antibody, in patients with relapsed or refractory cutaneous T-cell lymphoma: an international, first-in-human, open-label, phase 1 trial. [2020]
IPH4102, a humanized KIR3DL2 antibody with potent activity against cutaneous T-cell lymphoma. [2020]
CCR4-IL2 bispecific immunotoxin is more effective than brentuximab for targeted therapy of cutaneous T-cell lymphoma in a mouse CTCL model. [2023]
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