Treatment for patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma
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
This study is testing a new treatment called IPH6501 to see if it can help people with advanced B-cell non-Hodgkin lymphoma who have already tried other options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innate Pharma Industry-sponsored |
| Drugs / interventions | rituximab, CAR-T, Chimeric Antigen Receptor, chemotherapy, immunotherapy |
| Locations | 14 sites (Duarte, California and 13 other locations) |
| Trial ID | NCT06088654 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced, histologically confirmed CD20+ B-cell non-Hodgkin lymphoma who have received at least two prior systemic therapies.
Not a fit: Patients with another invasive malignancy in the last two years or those who have not received prior anti-CD20 antibody therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with relapsed or refractory B-cell non-Hodgkin lymphoma who have exhausted other therapies.
How similar studies have performed: Other studies utilizing NK cell engagers have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 13 other locations
- 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)
- Icahn School Of Medicine At Mount Sinai — New York, New York, United States (Active_not_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)
- Peninsula Private Hospital — Frankston, Victoria, Australia (Recruiting)
- Austin Health — Heidelberg, Australia (Recruiting)
- Institute Bergonie — Bordeaux, France (Recruiting)
- Centre Hospitalier Regional Universitaire de Lille — Lille, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- Hôpital de la Coception — Marseille, France (Not_yet_recruiting)
- Centre Hospitalier Universitaire de Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Innate pharma
- Email: clinical.trials@innate-pharma.fr
- Phone: +33430303030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.