Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma

Launched by INNATE PHARMA · Oct 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IPH6501 for patients with a type of cancer known as B-Cell Non-Hodgkin Lymphoma, which is a cancer that affects the lymphatic system. The main goal of the study is to find out how safe this treatment is and to determine the best dose for future studies. This trial is open to adults aged 65 and older who have already tried at least two different treatments for their cancer but are still facing challenges with their disease.

To participate, patients must have a confirmed diagnosis of specific types of B-Cell Non-Hodgkin Lymphoma and should not have had any other major cancer treatments in the last month. Participants will receive the new treatment and will be monitored closely by doctors to assess how well they tolerate it. It's important to note that certain health conditions, such as a history of serious infections or other cancers, may prevent someone from joining the study. Overall, this trial offers a potential new option for patients dealing with advanced lymphoma who have limited treatment choices.

Gender

ALL

Eligibility criteria

• • Main 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