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A Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma


Description

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.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 lymphoma.

Trial Eligibility

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

Study Info

Organization

Innate Pharma


Primary Outcome

Safety and tolerability


Outcome Timeframe From time of informed consent through treatment period and including the follow-up: up to 22 months

NCTID NCT06088654

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2024-03-04

Completion Date 2028-12-31

Enrollment Target 184

Interventions

DRUG IPH6501

Locations Recruiting

City of Hope

United States, California, Duarte


Cedars Sinai

United States, California, Los Angeles


Siteman Cancer Center

United States, Missouri, Saint Louis


Memorial Sloan Kettering Cancer Center

United States, New York, New York


Wollongong Private Hospital

Australia, New South Wales, Wollongong


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