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Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
Trial Status: active
This is an international, first-in-human, multicenter, open-label Phase 1/2 study to
evaluate the safety profile, tolerability of IPH6501, and determine the recommended phase
2 dose (RP2D) for patients with B-Cell non-Hodgkin lymphoma.
Inclusion Criteria
Patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin's lymphoma (NHL) including the following types defined by WHO 2016: Diffuse Large B Cell Lymphoma (DLBCL); high grade; thymic; Follicular Lymphoma (FL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL)
Relapsed, progressive and/or refractory disease without established alternative therapy
Must have received at least 2 prior systemic therapies including at a minimum anti-CD20 antibody therapy (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Adequate organ and hematological function
Able to provide a fresh biopsy from a safely accessible site (or historical biopsy), per investigator determination. Main
Exclusion Criteria
Patients with another invasive malignancy in the last 2 years
Prior chemotherapy, immunotherapy or other anti-cancer therapy within less than 4 weeks before study drug administration.
Autologous stem cell transplant or treatment with CAR-T (Chimeric Antigen Receptor T-Cell) cell therapy within 100 days prior to first dose of study drug
Subjects with brain or subdural metastases are not eligible, nor those with history of central nervous system (CNS) lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C
Major surgery within 4 weeks before the first dose of study drug
Comorbidities including diabetes, cardiovascular diseases, immunodeficiencies/autoimmune condition
Pregnant / breastfeeding woman
Additional locations may be listed on ClinicalTrials.gov for NCT06088654.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
In Phase 1 - Dose finding, patients with advanced histologically confirmed, documented
CD20+ B-cell non-Hodgkin lymphoma (NHL) will be enrolled. The dose finding part will
include 2 sub-parts: Dose escalation will determine the Maximum Tolerated Dose (MTD) or
the highest tested dose, Dose assessment will determine RP2D.
In Phase 2 - Dose expansion, one or more cohorts will be selected with patients with
subtypes of advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin