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

April 9, 2026 updated by: Innate Pharma

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Heidelberg, Australia
        • Austin Health
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Private Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Frankston, Victoria, Australia, 3910
        • Peninsula Private Hospital
  • France
      • Bordeaux, France
        • Institute Bergonié
      • Lille, France
        • Centre Hospitalier Régional Universitaire de Lille
      • Lyon, France, 69002
        • Hospices Civils de Lyon
      • Marseille, France, 13005
        • Hôpital de la Coception
      • Nantes, France
        • Centre Hospitalier Universitaire De Nantes
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90048
        • Cedars Sinai
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Siteman Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPH6501 monotherapy
Drug: IPH6501
phase 1 (dose finding) and phase 2 (dose expansion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
To evaluate the safety profile (including dose limiting toxicities (DLT(s), the maximum tolerated dose (MTD) or highest tested dose), tolerability and determine the recommended phase 2 dose (RP2D)
From time of informed consent through treatment period and including the follow-up: up to 22 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
To investigate any preliminary antitumor activity
From time of informed consent through treatment period and including the follow-up: up to 22 months
Duration Of Response (DoR)
Time Frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
To investigate any preliminary antitumor activity
From time of informed consent through treatment period and including the follow-up: up to 22 months
Progression Free Survival (PFS)
Time Frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
To investigate any preliminary antitumor activity
From time of informed consent through treatment period and including the follow-up: up to 22 months
Maximum Observed Plasma Concentration (Cmax)
Time Frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
To characterize and evaluate the pharmacokinetic profile of IPH6501
From time of informed consent through treatment period and including the follow-up: up to 22 months
Area Under the Plasma Concentration (AUC)
Time Frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
To characterize and evaluate the pharmacokinetic profile of IPH6501
From time of informed consent through treatment period and including the follow-up: up to 22 months
Incidence of antidrug antibodies (ADA) against IPH6501
Time Frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
To evaluate the immunogenicity of IPH6501
From time of informed consent through treatment period and including the follow-up: up to 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innate Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Actual)

February 6, 2026

Study Completion (Actual)

February 6, 2026

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPH6501-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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