Non Hodgkin Lymphoma
Conditions
Keywords
ANKET®, NK cell engager, tetraspecific NK cell engager
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.
Interventions
DRUGIPH6501
phase 1 (dose finding) and phase 2 (dose expansion)
Sponsors
Innate Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | From time of informed consent through treatment period and including the follow-up: up to 22 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From time of informed consent through treatment period and including the follow-up: up to 22 months | To investigate any preliminary antitumor activity |
| Duration Of Response (DoR) | From time of informed consent through treatment period and including the follow-up: up to 22 months | To investigate any preliminary antitumor activity |
| Progression Free Survival (PFS) | From time of informed consent through treatment period and including the follow-up: up to 22 months | To investigate any preliminary antitumor activity |
| Maximum Observed Plasma Concentration (Cmax) | From time of informed consent through treatment period and including the follow-up: up to 22 months | To characterize and evaluate the pharmacokinetic profile of IPH6501 |
| Area Under the Plasma Concentration (AUC) | From time of informed consent through treatment period and including the follow-up: up to 22 months | To characterize and evaluate the pharmacokinetic profile of IPH6501 |
| Incidence of antidrug antibodies (ADA) against IPH6501 | From time of informed consent through treatment period and including the follow-up: up to 22 months | To evaluate the immunogenicity of IPH6501 |
Countries
Australia, France, United States
Outcome results
None listed