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

ID#: NCT06088654

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: March 04, 2024

End Date: December 31, 2028

Contact Information:
Innate pharma
+33430303030
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.
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