IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Purpose

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.

Conditions

  • NHL
  • Multiple Myeloma
  • Blood Cancer
  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non-Hodgkin Lymphoma
  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: Single Agent IDP-023 - Single Dose 		NHL or MM patient treated with a single dose of IDP-023 monotherapy
  • Drug: IDP-023
    NK cell therapy
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug: Fludarabine
    Lymphodepleting chemotherapy
  • Drug: Mesna
    Chemoprotectant
Experimental
Phase 1: Single Agent IDP-023 - Multiple Doses 		NHL and MM patients treated with multiple doses of IDP-023 monotherapy
  • Drug: IDP-023
    NK cell therapy
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug: Fludarabine
    Lymphodepleting chemotherapy
  • Drug: Mesna
    Chemoprotectant
Experimental
Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 		NHL and MM patients treated with multiple doses of IDP-023 monotherapy
  • Drug: IDP-023
    NK cell therapy
  • Drug: Interleukin-2
    Immune cytokine
    Other names:
    • Proleukin
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug: Fludarabine
    Lymphodepleting chemotherapy
  • Drug: Mesna
    Chemoprotectant
Experimental
Phase 2: Combination IDP-023 plus rituximab 		NHL patients treated with multiple doses of IDP-023 in combination with rituximab
  • Drug: IDP-023
    NK cell therapy
  • Drug: Rituximab
    Anti-CD20 antibody therapy
    Other names:
    • Rituxan
  • Drug: Interleukin-2
    Immune cytokine
    Other names:
    • Proleukin
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug: Fludarabine
    Lymphodepleting chemotherapy
  • Drug: Mesna
    Chemoprotectant
Experimental
Phase 2: Combination IDP-023 plus daratumumab 		MM patients treated with multiple doses of IDP-023 in combination with daratumumab
  • Drug: IDP-023
    NK cell therapy
  • Drug: Daratumumab
    Anti-CD38 antibody therapy
    Other names:
    • Darzalex
  • Drug: Interleukin-2
    Immune cytokine
    Other names:
    • Proleukin
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug: Fludarabine
    Lymphodepleting chemotherapy
  • Drug: Mesna
    Chemoprotectant
Experimental
Phase 2: Combination IDP-023 plus isatuximab 		MM patients treated with multiple doses of IDP-023 in combination with isatuximab
  • Drug: IDP-023
    NK cell therapy
  • Drug: Interleukin-2
    Immune cytokine
    Other names:
    • Proleukin
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug: Fludarabine
    Lymphodepleting chemotherapy
  • Drug: Mesna
    Chemoprotectant
  • Drug: Isatuximab
    Anti-CD38 antibody therapy
    Other names:
    • Sarclisa

Recruiting Locations

Valkyrie Clinical Trials
Los Angeles, California 90670
Contact:
Myo Zaw
626-632-1963
myo.zaw@vctcare.com

Emory University Hospital
Atlanta, Georgia 30322

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Kayla Wagenmann, MN, RN, PHN
612-624-2342
wage0074@umn.edu

Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
Contact:
Catalina Gonzalez-Pinzon
336-716-2957
cagonzal@wakehealth.edu

University Hospitals Cleveland
Cleveland, Ohio 44106
Contact:
UH Seidman Cancer Center Cancer Information Service Line
844-885-9659

Rhode Island Hospital
Providence, Rhode Island 02903
Contact:
Stephen Donnelly
401-444-4822
SDonnelly1@Lifespan.org

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Briana Smith
615-329-7449
briana.smith@scri.com

University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Christy Allen
281-455-0250
callen6@mdanderson.org

NEXT Oncology Virginia
Fairfax, Virginia 22031
Contact:
Blake Patterson
703-783-4505
bpatterson@nextoncology.com

More Details

Status
Recruiting
Sponsor
Indapta Therapeutics, INC.

Study Contact

Indapta Therapeutics, Inc.
TRIALS@INDAPTA.COM

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.