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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an expected average of 2 years
Awards & highlights
TELLOMAK Trial 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.Check my eligibility
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.See study design
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.
TELLOMAK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTELLOMAK Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Immunogenicity of IPH4102 alone (All cohorts)
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)
+7 moreTELLOMAK 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
Find a Location
Who is running the clinical trial?
Innate PharmaLead Sponsor
27 Previous Clinical Trials
2,871 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stage IVA or IVB SS, received at least two treatments, had mogamulizumab, and can have a skin biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing
- Group 2: Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing
- Group 3: Cohort 1: Relapsed/refractory Sezary Syndrome
- Group 4: Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many different hospitals or other settings is this trial being conducted?
"There are 18 total sites for this trial, but a few notable locations include Inova Health Care Services in Fairfax, Virginia, University of Alabama at Birmingham in Birmingham, Alabama, and Irvine Medical Center in Orange, California."
Answered by AI
Is this a novel clinical trial?
"Since 2019, IPH4102 has undergone extensive research and trials. The first study was conducted in 2019 by Innate Pharma. After the successful completion of this 166-person trial, IPH4102 received Phase 2 drug approval. Currently, there are two active clinical trials involving this medication taking place across 9 countries and 15 different cities."
Answered by AI
Are there any other research papers that mention IPH4102?
"Dermatology, Ruhr-University Bochum was the first to study IPH4102 in 2019. With 1 completed trial and 2 ongoing studies, research is being conducted both domestically and internationally."
Answered by AI
Can people with the qualifying condition participate in this research project at this time?
"The aforementioned website confirms that this clinical trial is looking for more participants. This study was initially posted on May 22nd, 2019 and has since been edited on June 16th, 2022."
Answered by AI
Has IPH4102 undergone the process of FDA approval?
"IPH4102 safety is estimated to be a 2. While there is some evidence supporting its general safety, there is no data to suggest that it is an effective treatment."
Answered by AI
How many people will be taking part in this experiment at most?
"Innate Pharma, the sponsor of this study, needs to recruit 166 patients that meet the eligibility requirements. The trial will take place in Inova Health Care Services and University of Alabama at Birmingham."
Answered by AI
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