RecruitingPhase 1Phase 2NCT06088654
Phase1/2 Study of IPH6501 in Patients With Relapsed /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
Sponsor
Innate Pharma
Enrollment
184 participants
Start Date
Mar 4, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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.
Exclusion Criteria9
- 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
Interventions
DRUGIPH6501
phase 1 (dose finding) and phase 2 (dose expansion)
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06088654
Related Trials
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
NCT0516951526 locations
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
NCT05006716120 locations
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
NCT06418204467 locations
CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma
NCT060263191 location
GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
NCT068750631 location