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

RECRUITINGPhase 1/2Sponsored by Innate Pharma
Actively Recruiting
PhasePhase 1/2
SponsorInnate Pharma
Started2024-03-04
Est. completion2028-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →

NCT06088654

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerNon-hodgkin Lymphoma

Locations5 sites

California

2 sites
City of Hope
Duarte, California, 91010
Swetha K Thiruvengadam, MD
Cedars Sinai
Los Angeles, California, 90048
Akil Merchant, MD

Missouri

1 site
Siteman Cancer Center
St Louis, Missouri, 63110
Dilan Patel, MD

New York

2 sites
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lorenzo Falchi, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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