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

Phase 1

Recruiting

• Conditions: Non Hodgkin Lymphoma
• Interventions: Drug: IPH6501

• Registration Number: NCT06088654
• Lead Sponsor: Innate Pharma

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 patients with B-Cell non-Hodgkin lymphoma.

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 Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2024-03-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPH6501 monotherapy	IPH6501	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	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)

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Icahn School Of Medicine At Mount Sinai; 🇺🇸 New York, New York, United States

Hôpital de la Coception; 🇫🇷 Marseille, France

City of Hope; 🇺🇸 Duarte, California, United States

Cedars Sinai; 🇺🇸 Los Angeles, California, United States

Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, 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

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France