IPH4102 for Cutaneous T-Cell Lymphoma

(TELLOMAK Trial)

Recruiting at 60 trial locations

Overseen By Innate Pharma

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Innate Pharma

No Placebo Group

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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.

Additional inclusion criteria applicable to all cohorts: Male or Female, at least 18 years of age; ECOG performance status ≤2; The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy and the first dose of IPH4102; Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia;

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.

Treatment Details

Interventions

• IPH4102 (Monoclonal Antibodies)

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.

Participant Groups

Group I: Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing Experimental Treatment 1 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 Treatment 1 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 expressing Experimental Treatment 1 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 Syndrome Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Innate Pharma

Lead Sponsor

Trials

29

Recruited

3,100+