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

Non Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088654
• Other study ID #: IPH6501-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 4, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: Innate Pharma
• Contact: Innate pharma
• Phone: +33430303030
• Email: clinical.trials[@]innate-pharma.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Drug:
• IPH6501
phase 1 (dose finding) and phase 2 (dose expansion)

Locations

Country	Name	City	State
Australia	Monash Health	Clayton	Victoria
Australia	Peninsula Private Hospital	Frankston	Victoria
Australia	Wollongong Private Hospital	Wollongong	New South Wales
France	Centre Hospitalier Regional Universitaire de Lille	Lille
France	Hospices Civils de Lyon	Lyon
France	Centre Hospitalier Universitaire de Nantes	Nantes
United States	City of Hope	Duarte	California
United States	Cedars Sinai	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Innate Pharma

Countries where clinical trial is conducted

United States,  Australia,  France, 

Outcome

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