NCT06119685 · Indapta Therapeutics, INC.
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
IDP-023
NK cell therapy
DRUG
Rituximab
Anti-CD20 antibody therapy
DRUG
Daratumumab
Anti-CD38 antibody therapy
DRUG
Interleukin-2
Immune cytokine
DRUG
Cyclophosphamide
Lymphodepleting chemotherapy
DRUG
Fludarabine
Lymphodepleting chemotherapy
DRUG
Mesna
Chemoprotectant
DRUG
Isatuximab
Anti-CD38 antibody therapy
Primary outcome measures
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Time frame: 1 year
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
Time frame: up to 21 days
Escalation Period
Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
Time frame: up to 21 days
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
Time frame: up to 35 days
Escalation Period
Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
Time frame: up to 35 days
Escalation Period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Time frame: 1 year
Escalation Period
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
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2)
Time frame: 2 years
Expansion period
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
- Lake Mary, Florida
- Atlanta, Georgia
- Minneapolis, Minnesota
- New York, New York
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Portland, Oregon
- Providence, Rhode Island
- Nashville, Tennessee
- Houston, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2025 · Source of record for eligibility and locations