Trial Title:
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
NCT ID:
NCT06119685
Condition:
NHL
Multiple Myeloma
Blood Cancer
Refractory Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Conditions: Official terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Hematologic Neoplasms
Cyclophosphamide
Rituximab
Fludarabine
Interleukin-2
Daratumumab
Conditions: Keywords:
Advanced Hematologic Cancers
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
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
daratumumab or rituximab.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IDP-023
Description:
NK cell therapy
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
Arm group label:
Phase 1: Single Agent IDP-023 - Single Dose
Arm group label:
Phase 2: Combination IDP-023 plus daratumumab
Arm group label:
Phase 2: Combination IDP-023 plus rituximab
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Anti-CD20 antibody therapy
Arm group label:
Phase 2: Combination IDP-023 plus rituximab
Other name:
Rituxan
Intervention type:
Drug
Intervention name:
Daratumumab
Description:
Anti-CD38 antibody therapy
Arm group label:
Phase 2: Combination IDP-023 plus daratumumab
Other name:
Darzalex
Intervention type:
Drug
Intervention name:
Interleukin-2
Description:
Immune cytokine
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
Arm group label:
Phase 2: Combination IDP-023 plus daratumumab
Arm group label:
Phase 2: Combination IDP-023 plus rituximab
Other name:
Proleukin
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Lymphodepleting chemotherapy
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
Arm group label:
Phase 1: Single Agent IDP-023 - Single Dose
Arm group label:
Phase 2: Combination IDP-023 plus daratumumab
Arm group label:
Phase 2: Combination IDP-023 plus rituximab
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Lymphodepleting chemotherapy
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
Arm group label:
Phase 1: Single Agent IDP-023 - Single Dose
Arm group label:
Phase 2: Combination IDP-023 plus daratumumab
Arm group label:
Phase 2: Combination IDP-023 plus rituximab
Intervention type:
Drug
Intervention name:
Mesna
Description:
Chemoprotectant
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses
Arm group label:
Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
Arm group label:
Phase 1: Single Agent IDP-023 - Single Dose
Arm group label:
Phase 2: Combination IDP-023 plus daratumumab
Arm group label:
Phase 2: Combination IDP-023 plus rituximab
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 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 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 daratumumab and
advanced NHL in combination with rituximab.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90670
Country:
United States
Status:
Recruiting
Contact:
Last name:
Myo Zaw
Phone:
626-632-1963
Email:
myo.zaw@vctcare.com
Facility:
Name:
Stanford University
Address:
City:
Stanford
Zip:
94304
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
Address:
City:
Lake Mary
Zip:
32746
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lacey Gebben
Contact backup:
Phone:
407-804-6133
Phone ext:
26446
Email:
lacey.gebben@flcancer.com
Facility:
Name:
Emory University Hospital
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kayla Wagenmann, MN, RN, PHN
Phone:
612-624-2342
Email:
wage0074@umn.edu
Facility:
Name:
NYP/Weill Cornell Medical Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anita Margarette Bayya Ventura
Phone:
646-962-9336
Email:
abv4001@med.cornell.edu
Facility:
Name:
Atrium Health Wake Forest Baptist
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University Hospitals Cleveland
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Providence Cancer Institute Franz Clinic
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katrina Herz
Phone:
503-215-2617
Email:
Katrina.Herz@providence.org
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephen Donnelly
Phone:
401-444-4822
Email:
SDonnelly1@Lifespan.org
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Briana Smith
Phone:
615-329-7449
Email:
briana.smith@scri.com
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christy Allen
Phone:
281-455-0250
Email:
callen6@mdanderson.org
Facility:
Name:
NEXT Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Phone:
703-783-4505
Email:
bpatterson@nextoncology.com
Start date:
October 25, 2023
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Indapta Therapeutics, INC.
Agency class:
Industry
Source:
Indapta Therapeutics, INC.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06119685
