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

NCT06088654 | Terminated Phase 1 FDA Drug

• 1 other identifier: IPH6501-101
• Study Type: interventional
• Target: 23
• Locations: 3 countries
• Sites: 14

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.

Conditions

Non Hodgkin Lymphoma

Keywords

ANKET®; NK cell engager; tetraspecific NK cell engager

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  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 Outcomes (6)

• Objective Response Rate (ORR)

  From time of informed consent through treatment period and including the follow-up: up to 22 months

• Duration Of Response (DoR)

  From time of informed consent through treatment period and including the follow-up: up to 22 months

• Progression Free Survival (PFS)

  From time of informed consent through treatment period and including the follow-up: up to 22 months

• Maximum Observed Plasma Concentration (Cmax)

  From time of informed consent through treatment period and including the follow-up: up to 22 months

• Area Under the Plasma Concentration (AUC)

  From time of informed consent through treatment period and including the follow-up: up to 22 months

Study Arms (1)

IPH6501 monotherapy

EXPERIMENTAL

Drug: IPH6501

Interventions

IPH6501 DRUG

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

IPH6501 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (14)

City of Hope

Duarte, California, 91010, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Icahn School Of Medicine At Mount Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Wollongong Private Hospital

Wollongong, New South Wales, 2500, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Peninsula Private Hospital

Frankston, Victoria, 3910, Australia

Location

Austin Health

Heidelberg, Australia

Location

Institute Bergonie

Bordeaux, France

Location

Centre Hospitalier Regional Universitaire de Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

Hôpital de la Coception

Marseille, 13005, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: March 4, 2024
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); AU (4); FR (5)