Phase 1/2 Study of IPH6501 in Patients with Relapsed or Hard-to-Treat B-Cell Non-Hodgkin Lymphoma

Sponsor: Innate Pharma

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06088654

Provider View

This clinical trial is testing a new drug, IPH6501, to see if it is safe and well-tolerated in patients with B-Cell Non-Hodgkin Lymphoma that has returned or is difficult to treat. The study will also determine the best dose for future research.

Patient Parameters

Program Overview

This international study is the first time IPH6501 is being tested in humans. It involves multiple centers and is open-label, meaning both doctors and participants know what treatment is being given. The study aims to evaluate the safety and tolerability of IPH6501 and to find the best dose for patients with B-Cell Non-Hodgkin Lymphoma (NHL).

Description

The study is divided into two phases:

In Phase 1, researchers will focus on finding the right dose of IPH6501. This phase includes two parts:

  • Dose Escalation: This part will help determine the highest dose that patients can tolerate without severe side effects.
  • Dose Assessment: This part will identify the recommended dose for Phase 2.

In Phase 2, the study will expand to include more patients with specific subtypes of advanced B-Cell Non-Hodgkin Lymphoma. This phase will further evaluate the effectiveness and safety of the recommended dose from Phase 1.

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

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