Clinical trial NCT06088654: Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non Hodgkin Lymphoma
Keywords: ANKET®
NK cell engager
tetraspecific NK cell engager
Lead sponsor: Innate Pharma
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability
timeFrame: From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From time of informed consent through treatment period and including the follow-up: up to 22 months
measure: Duration Of Response (DoR)
timeFrame: From time of informed consent through treatment period and including the follow-up: up to 22 months
measure: Progression Free Survival (PFS)
timeFrame: From time of informed consent through treatment period and including the follow-up: up to 22 months
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: From time of informed consent through treatment period and including the follow-up: up to 22 months
measure: Area Under the Plasma Concentration (AUC)
timeFrame: From time of informed consent through treatment period and including the follow-up: up to 22 months
measure: Incidence of antidrug antibodies (ADA) against IPH6501
timeFrame: From time of informed consent through treatment period and including the follow-up: up to 22 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Saint Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: New York
country: United States
facility: Icahn School Of Medicine At Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Wollongong
country: Australia
facility: Wollongong Private Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Private Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
city: Bordeaux
country: France
facility: Institute Bergonie
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital de la Coception
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
Study officials:
References: