Ended Therapeutic exploratory (Phase II) Advanced T-Cell Lymphomas (TCL), i.e. Cutaneous T Cell Lymphomas (CTCL) CTCL subtypes under investigation: relapsed/refractory Sézary Syndrome (SS), stage IB to IV Mycosis Fungoides (MF).

Study of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell Lymphoma.

EU CTIS ID: 2023-507777-18-00

What this study is testing

To evaluate the objective response rate (ORR).

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

SS patients (Cohort 1): 1. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies.
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 priortherapy 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, - Creatinine clearance ≥30 mL/min, calculated with the Cockcroft & Gault formula, - 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.

You likely can't join if

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

See the full eligibility criteria

Who can join

SS patients (Cohort 1): 1. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies.
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 priortherapy 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, - Creatinine clearance ≥30 mL/min, calculated with the Cockcroft & Gault formula, - 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.
SS patients (Cohort 1): 2. Prior treatment with mogamulizumab.
SS patients (Cohort 1): 3. Patients should have blood stage B2 at screening based on central evaluation by flow cytometry.
SS patients (Cohort 1): 4. Feasibility of obtaining at least one skin biopsy at screening.
MF patients (Cohorts 2 and All comers): 5. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF.
MF patients (Cohorts 2 and All comers): 6. Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC.
MF patients (Cohorts 2 and All comers): 7. Patients should have received at least two prior systemic therapies.
MF patients (Cohorts 2 and All comers): 8. Feasibility of obtaining at least one skin biopsy at screening.
9. Male or Female, at least 18 years of age.

What rules you out

1. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening.
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.
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: nonmelanoma 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. 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).
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.
10. 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.
11. Known or tested positive for human immunodeficiency virus (HIV).
2. Receipt of live vaccines within 4 weeks prior the 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.

The study team makes the final eligibility decision.

Where it's taking place

United States
United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.