IDP-023 treatment for advanced blood cancers
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
PHASE1; PHASE2 · Indapta Therapeutics, INC. · NCT06119685
This study is testing a new treatment called IDP-023, which uses special immune cells alone and with other medications to see if it can help people with advanced blood cancers like multiple myeloma and non-Hodgkin lymphoma.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indapta Therapeutics, INC. (industry) |
| Drugs / interventions | chemotherapy, isatuximab, daratumumab, rituximab |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT06119685 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates IDP-023, an allogeneic NK cell therapy, administered alone and in combination with antibody therapies like isatuximab, daratumumab, and rituximab in patients with advanced hematologic cancers. The study is structured in two phases: a Phase 1 dose escalation to assess safety and determine optimal dosing, followed by a Phase 2 expansion to evaluate efficacy in patients with relapsed or refractory multiple myeloma and non-Hodgkin lymphoma. The trial aims to gather data on the safety, tolerability, and preliminary antitumor activity of these treatments.
Who should consider this trial
Good fit: Ideal candidates include patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma who have previously failed multiple lines of therapy.
Not a fit: Patients with significant cardiac issues, active infections, or untreated central nervous system metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced hematologic cancers who have limited treatment alternatives.
How similar studies have performed: Other studies using NK cell therapies and antibody combinations have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 11 other locations
- Valkyrie Clinical Trials — Los Angeles, California, United States (RECRUITING)
- Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center — Lake Mary, Florida, United States (WITHDRAWN)
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
- NYP/Weill Cornell Medical Center — New York, New York, United States (WITHDRAWN)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (RECRUITING)
- University Hospitals Cleveland — Cleveland, Ohio, United States (RECRUITING)
- Providence Cancer Institute Franz Clinic — Portland, Oregon, United States (WITHDRAWN)
- Rhode Island Hospital — Providence, Rhode Island, United States (RECRUITING)
- SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- NEXT Oncology Virginia — Fairfax, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Indapta Therapeutics, Inc.
- Email: TRIALS@INDAPTA.COM
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Advanced Hematologic Cancers