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

NCT06119685 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-06-03

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

IDP-023

NK cell therapy

DRUG

Rituximab

Anti-CD20 antibody therapy

DRUG

Daratumumab

Anti-CD38 antibody therapy

DRUG

Interleukin-2

Immune cytokine

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy

DRUG

Fludarabine

Lymphodepleting chemotherapy

DRUG

Mesna

Chemoprotectant

DRUG

Isatuximab

Anti-CD38 antibody therapy

Sponsors & Collaborators

  • Indapta Therapeutics, INC.

    lead INDUSTRY

Principal Investigators

  • Indapta Therapeutics, Inc. · Indapta Therapeutics, INC.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2025-12-30
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119685 on ClinicalTrials.gov