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Clinical Trials in the USA / NCT06119685
Recruiting Phase 1/2

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

NCT06119685 · tracked via the Priya Life Science USA tracker
Sponsor
Indapta Therapeutics, INC
Phase
Phase 1/2
Started
2023-10-25
Last updated
2025-06-03

Condition(s) studied

NHLMultiple MyelomaBlood CancerRefractory Non-Hodgkin LymphomaRelapsed Non-Hodgkin LymphomaRefractory Multiple MyelomaRelapsed Multiple Myeloma

Investigational drug(s) / intervention(s)

IDP-023Rituximab →Daratumumab →Interleukin-2 →Cyclophosphamide →Fludarabine →Mesna →Isatuximab →

IDP-023: NK cell therapy

Rituximab: Anti-CD20 antibody therapy

Daratumumab: Anti-CD38 antibody therapy

Interleukin-2: Immune cytokine

Cyclophosphamide: Lymphodepleting chemotherapy

Fludarabine: Lymphodepleting chemotherapy

Mesna: Chemoprotectant

Isatuximab: Anti-CD38 antibody therapy

Study 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 isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 Monotherapy - (Phase 1) — up to 21 days
    Escalation Period
  • 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 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) — up to 35 days
    Escalation Period
  • Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) — up to 35 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

Trial sites (12)

FacilityCityRegionStatus
Valkyrie Clinical Trials Los Angeles California Recruiting
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center Lake Mary Florida Withdrawn
Emory University Hospital Atlanta Georgia Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
NYP/Weill Cornell Medical Center New York New York Withdrawn
Atrium Health Wake Forest Baptist Winston-Salem North Carolina Recruiting
University Hospitals Cleveland Cleveland Ohio Recruiting
Providence Cancer Institute Franz Clinic Portland Oregon Withdrawn
Rhode Island Hospital Providence Rhode Island Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting

On this site

📄 Rituxan (rituximab) drug profile → 📄 Darzalex (daratumumab) drug profile →

Other trials for the same condition

A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy Recruiting
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM Active, not recruiting
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Recruiting
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06119685 on ClinicalTrials.gov ↗ ← All trials in the USA