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

• Status: Recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innate Pharma

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