Clinical Trials /

IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma

NCT03902184

Description:

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.

Related Conditions:
  • Mycosis Fungoides
  • Sezary Syndrome
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma
  • Official Title: TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: IPH4102-201
  • SECONDARY ID: 2018-003969-33
  • NCT ID: NCT03902184

Conditions

  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Mycosis Fungoides/Sezary Syndrome

Interventions

DrugSynonymsArms
IPH4102lacutamabCohort 1: Relapsed/refractory Sezary Syndrome

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1: Relapsed/refractory Sezary SyndromeExperimentalIPH4102 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.
  • IPH4102
Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressingExperimentalIPH4102 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.
  • IPH4102
Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressingExperimentalIPH4102 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.
  • IPH4102

Eligibility Criteria

        Inclusion criteria

        Patients must meet all of the inclusion criteria in order to be eligible to participate in
        the study.

        Cohort 1:

          1. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior
             systemic therapies;

          2. Prior treatment with mogamulizumab;

          3. Patients should have blood stage B2 at screening based on central evaluation by flow
             cytometry;

          4. Feasibility of obtaining at least one skin biopsy at screening;

             Cohorts 2 and 3:

          5. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;

          6. KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) in at least one skin lesion
             based on central evaluation by IHC;

          7. Patients should have received at least two prior systemic therapies;

          8. Feasibility of obtaining at least one skin biopsy at screening;

             Additional inclusion criteria applicable to all cohorts:

          9. Male or Female, at least 18 years of age;

         10. ECOG performance status ≤2;

         11. 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;

         12. Patients should have recovered from all non-hematological adverse events related to
             prior therapy to ≤ grade 1 except for alopecia;

         13. 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,

               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 X ULN;

         14. 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;

         15. 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;

         16. Signed informed consent form prior to any protocol-specific procedures.

        Exclusion Criteria:

        Patients meeting any of the following exclusion criteria will not be eligible to
        participate in the study:

          1. Patients with evidence of large cell transformation (LCT) based on central histologic
             evaluation at screening;

          2. Receipt of live vaccines within 4 weeks prior to treatment;

          3. Central nervous system (CNS) lymphoma involvement;

          4. Prior administration of IPH4102;

          5. Concurrent enrollment in another clinical trial, unless it is an observational (non -
             interventional) clinical study or the follow-up period of an interventional study;

          6. Autologous stem cell transplantation less than 3 months prior to enrollment;

          7. Prior allogenic transplantation;

          8. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;

          9. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral,
             bacterial, or fungal infection;

         10. Patients who have active Hepatitis B or C virus infection;

         11. Known or tested positive for human immunodeficiency virus (HIV);

         12. 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;

         13. Pregnant or breastfeeding women;

         14. Patients with congestive heart failure, Class III or IV, by New York Heart Association
             (NYHA) criteria;

         15. Patients with autoimmune disease on systemic immunosuppressive treatment;

         16. 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;

         17. Patients with dementia or altered mental status that would preclude understanding and
             rendering of informed consent document.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:Using the Olsen (2011, JCO) criteria (All cohorts)

Secondary Outcome Measures

Measure:Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)
Time Frame:From first dose until study completion, an expected average of 2 years
Safety Issue:
Description:patients with treatment-related adverse events as assessed by CTCAE v5.0
Measure:Quality of life (QoL) (All cohorts)
Time Frame:Through study completion, an expected average of 2 years
Safety Issue:
Description:Using the Skindex29 questionnaire to assesse the effects of skin disease on quality of life in three domains: Symptoms, Emotions, and Functioning
Measure:pruritus (All cohorts)
Time Frame:Through study completion, an expected average of 2 years
Safety Issue:
Description:Using Visual Analog Scale (VAS) for prutitus assessment: From 0 = No pruritus to 10 = Pruritus as bad as it could possibly be
Measure:ORR using blinded central review (Cohort 1)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:Using the Olsen (2011, JCO) criteria
Measure:Progression free survival (PFS) (All cohorts)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:
Measure:Overall survival (OS) (All cohorts)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:
Measure:PK parameters : Maximum Plasma Concentration of IPH4102 alone (All cohorts)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:Maximum Plasma Concentration (Cmax) (W1, W5)
Measure:PK parameters :Trough Concentration of IPH4102 alone (All cohorts)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:Trough Concentration (Ctrough) every 8 or 12 weeks
Measure:Immunogenicity of IPH4102 alone (All cohorts)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:A serum sample will be collected at the specified time points for evaluation of anti-drug antibodies (ADA).
Measure:Duration of Response (DOR)
Time Frame:From the first dose until study completion, an expected average of 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Innate Pharma

Last Updated

June 2, 2021