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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 escalation will determine the Maximum Tolerated Dose (MTD) or the highest tested dose, Dose assessment will determine RP2D.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Non Hodgkin Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IPH6501 monotherapy

Group Type EXPERIMENTAL

IPH6501

Intervention Type DRUG

phase 1 (dose finding) and phase 2 (dose expansion)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IPH6501

phase 1 (dose finding) and phase 2 (dose expansion)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Innate Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City of Hope

Duarte, California, United States

Site Status RECRUITING

Cedars Sinai

Los Angeles, California, United States

Site Status RECRUITING

Siteman Cancer Center

St Louis, Missouri, United States

Site Status RECRUITING

Icahn School Of Medicine At Mount Sinai

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Wollongong Private Hospital

Wollongong, New South Wales, Australia

Site Status RECRUITING

Monash Health

Clayton, Victoria, Australia

Site Status RECRUITING

Peninsula Private Hospital

Frankston, Victoria, Australia

Site Status RECRUITING

Austin Health

Heidelberg, , Australia

Site Status RECRUITING

Institute Bergonie

Bordeaux, , France

Site Status RECRUITING

Centre Hospitalier Regional Universitaire de Lille

Lille, , France

Site Status RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Hôpital de la Coception

Marseille, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Innate pharma

Role: CONTACT

+33430303030

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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

Review additional registry numbers or institutional identifiers associated with this trial.

IPH6501-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Patients Who Receive 131 I-MIBG
NCT04770831 WITHDRAWN