Trial Title:
Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
NCT ID:
NCT06088654
Condition:
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Conditions: Keywords:
ANKET®
NK cell engager
tetraspecific NK cell engager
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IPH6501
Description:
phase 1 (dose finding) and phase 2 (dose expansion)
Arm group label:
IPH6501 monotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swetha K Thiruvengadam, MD
Investigator:
Last name:
Swetha K Thiruvengadam, MD
Email:
Principal Investigator
Facility:
Name:
Cedars Sinai
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Akil Merchant, MD
Investigator:
Last name:
Akil Merchant, MD
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dilan Patel, MD
Investigator:
Last name:
Dilan Patel, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lorenzo Falchi, MD
Investigator:
Last name:
Lorenzo Falchi, MD
Email:
Principal Investigator
Facility:
Name:
Wollongong Private Hospital
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Peter Presgrave, MD
Investigator:
Last name:
Peter Presgrave, MD
Email:
Principal Investigator
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Gareth Gregory, MD
Investigator:
Last name:
Gareth Gregory, MD
Email:
Principal Investigator
Facility:
Name:
Peninsula Private Hospital
Address:
City:
Frankston
Zip:
3910
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Patricia Walker, MD
Investigator:
Last name:
Patricia Walker, MD
Email:
Principal Investigator
Facility:
Name:
Austin Health
Address:
City:
Heidelberg
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Geoffrey Chong, MD
Investigator:
Last name:
Geoffrey Chong, MD
Email:
Principal Investigator
Facility:
Name:
Institute Bergonie
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Fontanet Bijou, MD
Investigator:
Last name:
Fontanet Bijou, MD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Regional Universitaire de Lille
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck Morschhauser, MD
Investigator:
Last name:
Franck Morschhauser, MD
Email:
Principal Investigator
Facility:
Name:
Hospices Civils de Lyon
Address:
City:
Lyon
Zip:
69002
Country:
France
Status:
Recruiting
Contact:
Last name:
Emmanuel Bachy, MD
Investigator:
Last name:
Emmanuel Bachy, MD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Universitaire de Nantes
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Contact:
Last name:
Benoit Tessoulin, MD
Investigator:
Last name:
Benoit Tessoulin, MD
Email:
Principal Investigator
Start date:
March 4, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Innate Pharma
Agency class:
Industry
Source:
Innate Pharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06088654
