Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Single Agent IDP-023 - Single Dose | Experimental | NHL or MM patient treated with a single dose of IDP-023 monotherapy |
|
| Phase 1: Single Agent IDP-023 - Multiple Doses | Experimental | NHL and MM patients treated with multiple doses of IDP-023 monotherapy |
|
| Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 | Experimental | NHL and MM patients treated with multiple doses of IDP-023 monotherapy |
|
| Phase 2: Combination IDP-023 plus rituximab | Experimental | NHL patients treated with multiple doses of IDP-023 in combination with rituximab |
|
| Phase 2: Combination IDP-023 plus daratumumab | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-023 | Drug | NK cell therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) | Escalation Period | 1 year |
| Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) | Escalation Period | up to 21 days |
| Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) | Escalation Period | up to 21 days |
| Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) | Escalation Period | up to 35 days |
| Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) | Escalation Period | up to 35 days |
| Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) | Escalation Period | 1 year |
| 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) | Expansion period | 2 years |
| For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2) |
| Measure | Description | Time Frame |
|---|---|---|
| PK (Cmax) of IDP-023 - (Phase 1/2) | Escalation and expansion periods | 2 years |
| PK (AUC) of IDP-023 - (Phase 1/2) | Escalation and expansion periods |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Indapta Therapeutics, Inc. | Contact | TRIALS@INDAPTA.COM |
| Name | Affiliation | Role |
|---|---|---|
| Indapta Therapeutics, Inc. | Indapta Therapeutics, INC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valkyrie Clinical Trials | Recruiting | Los Angeles | California | 90670 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
MM patients treated with multiple doses of IDP-023 in combination with daratumumab |
|
| Phase 2: Combination IDP-023 plus isatuximab | Experimental | MM patients treated with multiple doses of IDP-023 in combination with isatuximab |
|
| Rituximab | Drug | Anti-CD20 antibody therapy |
|
|
| Daratumumab | Drug | Anti-CD38 antibody therapy |
|
|
| Interleukin-2 | Drug | Immune cytokine |
|
|
| Cyclophosphamide | Drug | Lymphodepleting chemotherapy |
|
| Fludarabine | Drug | Lymphodepleting chemotherapy |
|
| Mesna | Drug | Chemoprotectant |
|
| Isatuximab | Drug | Anti-CD38 antibody therapy |
|
|
Expansion period |
| 2 years |
| 2 years |
| 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) | Escalation period | 1 year |
| For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1) | Escalation period | 1 year |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) | Expansion period | 2 years |
| Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center | Withdrawn | Lake Mary | Florida | 32746 | United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| NYP/Weill Cornell Medical Center | Withdrawn | New York | New York | 10065 | United States |
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| University Hospitals Cleveland | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| Providence Cancer Institute Franz Clinic | Withdrawn | Portland | Oregon | 97213 | United States |
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
|
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| NEXT Oncology Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D019337 | Hematologic Neoplasms |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C556306 | daratumumab |
| D007376 | Interleukin-2 |
| C082598 | aldesleukin |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D015080 | Mesna |
| C000599209 | isatuximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D008222 | Lymphokines |
| D001685 | Biological Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
Not provided
Not provided