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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Indapta Therapeutics, INC.
Study ID
NCT06119685
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IDP-023 — DRUG
    NK cell therapy
  • 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

Study Details

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.

Key Dates

Start date
Oct 25, 2023
Status verified
Aug 2024
Primary completion
Dec 30, 2025
Completion
Dec 31, 2029

Study Design

Enrollment
128 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Single Agent IDP-023 - Single Dose
    NHL or MM patient treated with a single dose of IDP-023 monotherapy
  • Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses
    NHL and MM patients treated with multiple doses of IDP-023 monotherapy
  • Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
    NHL and MM patients treated with multiple doses of IDP-023 monotherapy
  • Experimental: Phase 2: Combination IDP-023 plus rituximab
    NHL patients treated with multiple doses of IDP-023 in combination with rituximab
  • Experimental: Phase 2: Combination IDP-023 plus daratumumab
    MM patients treated with multiple doses of IDP-023 in combination with daratumumab
  • Experimental: Phase 2: Combination IDP-023 plus isatuximab
    MM patients treated with multiple doses of IDP-023 in combination with isatuximab

Primary Outcome Measure

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [ Time Frame: 1 year ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90670
Myo Zaw
[email protected]
626-632-1963
Florida Cancer Specialists and Research Institute - Lake Mary Cancer CenterLake MaryFlorida32746-
Emory University HospitalAtlantaGeorgia30322-
University of MinnesotaMinneapolisMinnesota55455
Kayla Wagenmann, MN, RN, PHN
[email protected]
612-624-2342
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Catalina Gonzalez-Pinzon
[email protected]
336-716-2957
University Hospitals ClevelandClevelandOhio44106
UH Seidman Cancer Center Cancer Information Service Line
844-885-9659
Providence Cancer Institute Franz ClinicPortlandOregon97213-
Rhode Island HospitalProvidenceRhode Island02903
Stephen Donnelly
[email protected]
401-444-4822
SCRI Oncology PartnersNashvilleTennessee37203
Briana Smith
[email protected]
615-329-7449
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Christy Allen
[email protected]
281-455-0250
NEXT Oncology VirginiaFairfaxVirginia22031
Blake Patterson
[email protected]
703-783-4505

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