Blood Cancer, Multiple Myeloma, NHL, Refractory Multiple Myeloma, Refractory Non-Hodgkin Lymphoma, Relapsed Multiple Myeloma, Relapsed Non-Hodgkin Lymphoma
Conditions
Keywords
Advanced Hematologic Cancers
Brief summary
This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.
Detailed description
IDP-023 is an off-the-shelf, allogeneic cell product made of natural killer cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells. This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability, and preliminary antitumor activity in patients with relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), respectively. The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase. Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of different IDP-023 containing regimens and to define the recommended regimen and Phase 2 doses (RP2D) of IDP-023. Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate the safety and efficacy of IDP-023 in advanced MM in combination with isatuximab or daratumumab and advanced NHL in combination with rituximab.
Interventions
DRUGIDP-023
NK cell therapy
DRUGRituximab
Anti-CD20 antibody therapy
DRUGDaratumumab
Anti-CD38 antibody therapy
DRUGInterleukin-2
Immune cytokine
DRUGCyclophosphamide
Lymphodepleting chemotherapy
DRUGFludarabine
Lymphodepleting chemotherapy
DRUGMesna
Chemoprotectant
DRUGIsatuximab
Anti-CD38 antibody therapy
Sponsors
Indapta Therapeutics, INC.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy. * For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of greater than 12 weeks per the Investigator. Key
Exclusion criteria
* Impaired cardiac function or history of clinical significant cardiac disease. * Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection. * Active SARS-CoV-2 infection. * Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2) | 2 years | Expansion period |
| Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) | up to 21 days | Escalation Period |
| Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) | up to 35 days | Escalation Period |
| Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) | up to 35 days | Escalation Period |
| Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) | 1 year | Escalation Period |
| For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 2) | 2 years | Expansion period |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) | 1 year | Escalation Period |
| Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) | up to 21 days | Escalation Period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK (AUC) of IDP-023 - (Phase 1/2) | 2 years | Escalation and expansion periods |
| For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 1) | 1 year | Escalation period |
| For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1) | 1 year | Escalation period |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) | 2 years | Expansion period |
| PK (Cmax) of IDP-023 - (Phase 1/2) | 2 years | Escalation and expansion periods |
Countries
United States
Contacts
Primary ContactIndapta Therapeutics, Inc.
Outcome results
None listed