Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT06088654
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
184 participants
INTERVENTIONAL
2024-03-04
2028-12-31
Brief Summary
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Detailed Description
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In Phase 2 - Dose expansion, one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IPH6501 monotherapy
IPH6501
phase 1 (dose finding) and phase 2 (dose expansion)
Interventions
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IPH6501
phase 1 (dose finding) and phase 2 (dose expansion)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Innate Pharma
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
Cedars Sinai
Los Angeles, California, United States
Siteman Cancer Center
St Louis, Missouri, United States
Icahn School Of Medicine At Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wollongong Private Hospital
Wollongong, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Austin Health
Heidelberg, , Australia
Institute Bergonie
Bordeaux, , France
Centre Hospitalier Regional Universitaire de Lille
Lille, , France
Hospices Civils de Lyon
Lyon, , France
Hôpital de la Coception
Marseille, , France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Swetha K Thiruvengadam, MD
Role: primary
Akil Merchant, MD
Role: primary
Dilan Patel, MD
Role: primary
Lorenzo Falchi, MD
Role: primary
Peter Presgrave, MD
Role: primary
Jake Shortt, MD
Role: primary
Patricia Walker, MD
Role: primary
Geoffrey Chong, MD
Role: primary
Fontanet Bijou, MD
Role: primary
Franck Morschhauser, MD
Role: primary
Emmanuel Bachy, MD
Role: primary
Régis Costello, MD
Role: primary
Benoit Tessoulin, MD
Role: primary
Other Identifiers
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IPH6501-101
Identifier Type: -
Identifier Source: org_study_id
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