IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymp… (NCT03902184) | Clinical Trial Compass
CompletedPhase 2
IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma
United States170 participantsStarted 2019-05-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies;
✓. Prior treatment with mogamulizumab;
✓. Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
✓. Feasibility of obtaining at least one skin biopsy at screening;
✓. 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;
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;
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From the first dose until study completion, an expected average of 2 years