Recruiting
Phase 1
Phase 2

IDP-023, Antibody Therapies

Sponsor:

Indapta Therapeutics, INC.

Code:

NCT06119685

Conditions

NHL

Multiple Myeloma

Blood Cancer

Refractory Non-Hodgkin Lymphoma

Relapsed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IDP-023

Rituximab

Daratumumab

Interleukin-2

Cyclophosphamide

Study Details

Brief 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

Study ID

NCT06119685

Start date

Oct 25, 2023

Status verified date

Aug, 2024

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

128 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Indapta Therapeutics, Inc.

TRIALS@INDAPTA.COM

Locations

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90670

Contacts

Myo Zaw

626-632-1963myo.zaw@vctcare.com

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Kayla Wagenmann, MN, RN, PHN

612-624-2342wage0074@umn.edu

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Catalina Gonzalez-Pinzon

336-716-2957cagonzal@wakehealth.edu

University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

UH Seidman Cancer Center Cancer Information Service Line

844-885-9659

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Stephen Donnelly

401-444-4822SDonnelly1@Lifespan.org

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Briana Smith

615-329-7449briana.smith@scri.com

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Christy Allen

281-455-0250callen6@mdanderson.org

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

703-783-4505bpatterson@nextoncology.com

More Information

Sponsor

Indapta Therapeutics, INC.

Last update posted

Jun 3, 2025

Last verified

Aug, 2024

Keywords

  • Advanced Hematologic Cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indapta Therapeutics, INC. on 2025-06-03.