Back to resultsPhase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
Primary Purpose
Non Hodgkin Lymphoma
Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IPH6501
Sponsored by
About this trial
This is an interventional treatment trial for Non Hodgkin Lymphoma focused on measuring ANKET®, NK cell engager, tetraspecific NK cell engager
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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
- Monash Health
- Peninsula Private Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPH6501 monotherapy
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Objective Response Rate (ORR)
To investigate any preliminary antitumor activity
Duration Of Response (DoR)
To investigate any preliminary antitumor activity
Progression Free Survival (PFS)
To investigate any preliminary antitumor activity
Maximum Observed Plasma Concentration (Cmax)
To characterize and evaluate the pharmacokinetic profile of IPH6501
Area Under the Plasma Concentration (AUC)
To characterize and evaluate the pharmacokinetic profile of IPH6501
Incidence of antidrug antibodies (ADA) against IPH6501
To evaluate the immunogenicity of IPH6501
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06088654
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 7, 2023 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innate Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma
Keywords
ANKET®, NK cell engager, tetraspecific NK cell engager
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPH6501 monotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IPH6501
Intervention Description
phase 1 (dose finding) and phase 2 (dose expansion)
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
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)
Time Frame
From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
To investigate any preliminary antitumor activity
Time Frame
From time of informed consent through treatment period and including the follow-up: up to 22 months
Title
Duration Of Response (DoR)
Description
To investigate any preliminary antitumor activity
Time Frame
From time of informed consent through treatment period and including the follow-up: up to 22 months
Title
Progression Free Survival (PFS)
Description
To investigate any preliminary antitumor activity
Time Frame
From time of informed consent through treatment period and including the follow-up: up to 22 months
Title
Maximum Observed Plasma Concentration (Cmax)
Description
To characterize and evaluate the pharmacokinetic profile of IPH6501
Time Frame
From time of informed consent through treatment period and including the follow-up: up to 22 months
Title
Area Under the Plasma Concentration (AUC)
Description
To characterize and evaluate the pharmacokinetic profile of IPH6501
Time Frame
From time of informed consent through treatment period and including the follow-up: up to 22 months
Title
Incidence of antidrug antibodies (ADA) against IPH6501
Description
To evaluate the immunogenicity of IPH6501
Time Frame
From time of informed consent through treatment period and including the follow-up: up to 22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Innate pharma
Phone
+33430303030
Email
clinical.trials@innate-pharma.fr
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Falchi
First Name & Middle Initial & Last Name & Degree
Lorenzo Falchi
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Peninsula Private Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3910
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Walker
First Name & Middle Initial & Last Name & Degree
Patricia Walker
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
We'll reach out to this number within 24 hrs