Status:
RECRUITING
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Lead Sponsor:
Indapta Therapeutics, INC.
Conditions:
NHL
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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), a...
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 t...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06119685
Start Date
October 25 2023
End Date
December 31 2029
Last Update
June 3 2025
Active Locations (12)
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1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90670
2
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
Lake Mary, Florida, United States, 32746
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455