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NCT06119685 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06119685
Other study ID # Indapta-Trial-1
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 25, 2023
Est. completion date December 31, 2029

Study information
Verified date November 2023
Source Indapta Therapeutics, INC.
Contact Indapta Therapeutics, Inc.
Email TRIALS@INDAPTA.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 cancers.

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. 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 relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), respectively. The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase. Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of different IDP-023 containing regimens and to define the recommended regimen and Phase 2 doses (RP2D) of IDP-023. Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate the safety and efficacy of IDP-023 in advanced MM in combination with daratumumab and advanced NHL in combination with rituximab.

Recruitment information / eligibility
Status Recruiting
Enrollment 128
Est. completion date December 31, 2029
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
United States Emory University Hospital Atlanta Georgia
United States University Hospitals Cleveland Cleveland Ohio
United States NEXT Oncology Virginia Fairfax Virginia
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center Lake Mary Florida
United States University of Minnesota Minneapolis Minnesota
United States SCRI Oncology Partners Nashville Tennessee
United States NYP/Weill Cornell Medical Center New York New York
United States Providence Cancer Institute Franz Clinic Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Stanford University Stanford California
United States Atrium Health Wake Forest Baptist Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Indapta Therapeutics, INC.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) Escalation Period 1 year
Primary Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) Escalation Period up to 21 days
Primary Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) Escalation Period up to 21 days
Primary Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Daratumumab or Rituximab - (Phase 1) Escalation Period up to 35 days
Primary Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Daratumumab or Rituximab - (Phase 1) Escalation Period up to 35 days
Primary Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) Escalation Period 1 year
Primary 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) Expansion period 2 years
Primary For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2) Expansion period 2 years
Secondary PK (Cmax) of IDP-023 - (Phase 1/2) Escalation and expansion periods 2 years
Secondary PK (AUC) of IDP-023 - (Phase 1/2) Escalation and expansion periods 2 years
Secondary 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) Escalation period 1 year
Secondary For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1) Escalation period 1 year
Secondary Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) Expansion period 2 years
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