Status:
RECRUITING
Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
Innate Pharma
Conditions:
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 patient...
Detailed Description
In Phase 1 - Dose finding, patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma (NHL) will be enrolled. The dose finding part will include 2 sub-parts: Dose es...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06088654
Start Date
March 4 2024
End Date
December 31 2028
Last Update
April 2 2025
Active Locations (14)
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1
City of Hope
Duarte, California, United States, 91010
2
Cedars Sinai
Los Angeles, California, United States, 90048
3
Siteman Cancer Center
St Louis, Missouri, United States, 63110
4
Icahn School Of Medicine At Mount Sinai
New York, New York, United States, 10029