IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
- Registration Number
- NCT06119685
- Lead Sponsor
- Indapta Therapeutics, INC.
- 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 daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancer...
- 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.
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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1: Single Agent IDP-023 - Multiple Doses IDP-023 NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Single Dose IDP-023 NHL or MM patient treated with a single dose of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Single Dose Cyclophosphamide NHL or MM patient treated with a single dose of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 IDP-023 NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Single Dose Fludarabine NHL or MM patient treated with a single dose of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses Fludarabine NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses Mesna NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 2: Combination IDP-023 plus rituximab IDP-023 NHL patients treated with multiple doses of IDP-023 in combination with rituximab Phase 2: Combination IDP-023 plus rituximab Mesna NHL patients treated with multiple doses of IDP-023 in combination with rituximab Phase 2: Combination IDP-023 plus daratumumab IDP-023 MM patients treated with multiple doses of IDP-023 in combination with daratumumab Phase 2: Combination IDP-023 plus daratumumab Daratumumab MM patients treated with multiple doses of IDP-023 in combination with daratumumab Phase 1: Single Agent IDP-023 - Single Dose Mesna NHL or MM patient treated with a single dose of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses Cyclophosphamide NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 Cyclophosphamide NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 Interleukin-2 NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 Fludarabine NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 Mesna NHL and MM patients treated with multiple doses of IDP-023 monotherapy Phase 2: Combination IDP-023 plus rituximab Cyclophosphamide NHL patients treated with multiple doses of IDP-023 in combination with rituximab Phase 2: Combination IDP-023 plus rituximab Interleukin-2 NHL patients treated with multiple doses of IDP-023 in combination with rituximab Phase 2: Combination IDP-023 plus rituximab Rituximab NHL patients treated with multiple doses of IDP-023 in combination with rituximab Phase 2: Combination IDP-023 plus rituximab Fludarabine NHL patients treated with multiple doses of IDP-023 in combination with rituximab Phase 2: Combination IDP-023 plus daratumumab Interleukin-2 MM patients treated with multiple doses of IDP-023 in combination with daratumumab Phase 2: Combination IDP-023 plus daratumumab Mesna MM patients treated with multiple doses of IDP-023 in combination with daratumumab Phase 2: Combination IDP-023 plus daratumumab Cyclophosphamide MM patients treated with multiple doses of IDP-023 in combination with daratumumab Phase 2: Combination IDP-023 plus daratumumab Fludarabine MM patients treated with multiple doses of IDP-023 in combination with daratumumab
- Primary Outcome Measures
Name Time Method 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 Monotherapy - (Phase 1) up to 21 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
For NHL: Anti-tumor activity by objective response rate (ORR) - (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 in combination with Daratumumab or Rituximab - (Phase 1) up to 35 days Escalation Period
Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Daratumumab or Rituximab - (Phase 1) up to 35 days Escalation Period
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (13)
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Stanford, California, United States
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
🇺🇸Lake Mary, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
NYP/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
University Hospitals Cleveland
🇺🇸Cleveland, Ohio, United States
Providence Cancer Institute Franz Clinic
🇺🇸Portland, Oregon, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT Oncology Virginia
🇺🇸Fairfax, Virginia, United States