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

May 1, 2024 updated by: Indapta Therapeutics, INC.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Not yet recruiting
        • Stanford University
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Not yet recruiting
        • Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Kayla Wagenmann, MN, RN, PHN
          • Phone Number: 612-624-2342
          • Email: wage0074@umn.edu
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Atrium Health Wake Forest Baptist
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute Franz Clinic
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Not yet recruiting
        • Rhode Island Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • TriStar Centennial Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1: Single Agent IDP-023 - Single Dose
NHL or MM patient treated with a single dose of IDP-023 monotherapy
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: Fludarabine
Lymphodepleting chemotherapy
Drug: IDP-023
NK cell therapy
Drug: Mesna
Chemoprotectant
Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses
NHL and MM patients treated with multiple doses of IDP-023 monotherapy
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: Fludarabine
Lymphodepleting chemotherapy
Drug: IDP-023
NK cell therapy
Drug: Mesna
Chemoprotectant
Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
NHL and MM patients treated with multiple doses of IDP-023 monotherapy
Drug: Interleukin-2
Immune cytokine
Other Names:
  • Proleukin
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: Fludarabine
Lymphodepleting chemotherapy
Drug: IDP-023
NK cell therapy
Drug: Mesna
Chemoprotectant
Experimental: Phase 2: Combination IDP-023 plus rituximab
NHL patients treated with multiple doses of IDP-023 in combination with rituximab
Drug: Rituximab
Anti-CD20 antibody therapy
Other Names:
  • Rituxan
Drug: Interleukin-2
Immune cytokine
Other Names:
  • Proleukin
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: Fludarabine
Lymphodepleting chemotherapy
Drug: IDP-023
NK cell therapy
Drug: Mesna
Chemoprotectant
Experimental: Phase 2: Combination IDP-023 plus daratumumab
MM patients treated with multiple doses of IDP-023 in combination with daratumumab
Drug: Interleukin-2
Immune cytokine
Other Names:
  • Proleukin
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: Fludarabine
Lymphodepleting chemotherapy
Drug: IDP-023
NK cell therapy
Drug: Mesna
Chemoprotectant
Drug: Daratumumab
Anti-CD38 antibody therapy
Other Names:
  • Darzalex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Time Frame: 2 years
Expansion period
2 years
PK (Cmax) of IDP-023 - (Phase 1/2)
Time Frame: 2 years
Escalation and expansion periods
2 years
PK (AUC) of IDP-023 - (Phase 1/2)
Time Frame: 2 years
Escalation and expansion periods
2 years
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)
Time Frame: 1 year
Escalation period
1 year
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)
Time Frame: 1 year
Escalation period
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indapta Therapeutics, INC.

Investigators

  • Study Director: Indapta Therapeutics, Inc., Indapta Therapeutics, INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Indapta-Trial-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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