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Monoclonal Antibodies

IPH4102 for Cutaneous T-Cell Lymphoma (TELLOMAK Trial)

Phase 2

Waitlist Available

Research Sponsored by Innate Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

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

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an expected average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for people with Sezary Syndrome or Mycosis Fungoides.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of IPH4102 are not listed here, common ones for cancer drugs like this may include fatigue, nausea, skin reactions from biopsies or infusions, increased risk of infection due to weakened immune system response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an expected average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an expected average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an expected average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Immunogenicity of IPH4102 alone (All cohorts)

Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)

ORR using blinded central review (Cohort 1)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IPH4102

2015

Completed Phase 1

~50

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Innate PharmaLead Sponsor

27 Previous Clinical Trials

2,871 Total Patients Enrolled

Media Library

IPH4102 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03902184 — Phase 2

$T-Cell Lymphoma Research Study Groups: Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing, Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing, Cohort 1: Relapsed/refractory Sezary Syndrome, Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed)$