Treatment for patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, first-in-human, multicenter Phase 1/2 study evaluates the safety and tolerability of IPH6501 in patients with advanced CD20+ B-cell non-Hodgkin lymphoma. The study consists of a dose-finding Phase 1, which includes dose escalation to determine the Maximum Tolerated Dose (MTD) and a recommended Phase 2 dose (RP2D). In Phase 2, selected cohorts of patients with specific subtypes of the disease will receive the treatment to assess its efficacy. The study aims to provide a new therapeutic option for patients with limited treatment alternatives.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Cedars Sinai
  Los Angeles, California, United States Recruiting
• Siteman Cancer Center
  Saint Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Wollongong Private Hospital
  Wollongong, New South Wales, Australia Recruiting
• Monash Health
  Clayton, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Innate pharma
• Email: clinical.trials@innate-pharma.fr
• Phone: +33430303030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.