Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID06119685

Phase 1/2 Study of IDP-023 Alone and With Antibody Therapies in Advanced Blood Cancers

Led by Indapta Therapeutics, INC. · Updated on 2025-06-03

128

Participants Needed

12

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating IDP-023, an off-the-shelf cell therapy made of natural killer (NK) cells, in patients with advanced blood cancers including relapsed or refractory multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL). This open-label, first-in-human Phase 1/2 study aims to assess the safety, tolerability, and early anti-cancer effects of IDP-023 given alone or combined with immune therapies such as interleukin-2, isatuximab, daratumumab, or rituximab. The study is sponsored by Indapta Therapeutics, INC.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For multiple myeloma patients: diagnosed with multiple myeloma requiring systemic therapy and relapsed or refractory after at least 3 prior treatments
  • For non-Hodgkin's lymphoma patients: relapsed or refractory disease after at least 2 lines of chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than 12 weeks as assessed by the investigator
Not Eligible

You will not qualify if you...

  • Impaired heart function or history of significant heart disease
  • Infection with HIV, active hepatitis B, or hepatitis C
  • Active COVID-19 infection
  • Untreated central nervous system, epidural tumor metastasis, or brain metastasis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 year in Phase 1 and up to 2 years in Phase 2

Participants receive IDP-023 as a single agent or in combination with antibody therapies to treat advanced multiple myeloma or non-Hodgkin's lymphoma.

Multiple dosing visits according to assigned regimen

Follow-up

Duration - Up to 2 years

Participants are monitored for safety, tolerability, and anti-tumor activity after treatment.

Regular follow-up visits during the monitoring period

Trial Site Locations

Total: 12 locations

1

Valkyrie Clinical Trials

Los Angeles, California, United States, 90670

Actively Recruiting

2

Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center

Lake Mary, Florida, United States, 32746

Withdrawn

3

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

5

NYP/Weill Cornell Medical Center

New York, New York, United States, 10065

Withdrawn

6

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

7

University Hospitals Cleveland

Cleveland, Ohio, United States, 44106

Actively Recruiting

8

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

Withdrawn

9

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

10

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

11

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

12

NEXT Oncology Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

I

Indapta Therapeutics, Inc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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