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Monoclonal Antibodies

IDP-023 + Antibody Therapies for Blood Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Indapta Therapeutics, INC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test a new drug to treat advanced blood cancers, with safety, tolerability, and preliminary effectiveness monitored.

Who is the study for?

This trial is for adults with advanced blood cancers like Non-Hodgkin's Lymphoma or Multiple Myeloma who have tried at least two or three treatments without success. They should be relatively healthy otherwise, with a life expectancy over 12 weeks and able to perform daily activities with little to no assistance.Check my eligibility

What is being tested?

The study tests IDP-023 alone and combined with other drugs (Rituximab, Daratumumab) in different stages. It aims to find the safest dose that works best against these cancers. Some patients will also receive IL-2, Cyclophosphamide, Fludarabine, and Mesna as part of their treatment combinations.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as fever and chills, potential damage to organs from inflammation caused by the drug combination, fatigue from treatment-related anemia or general body stress, nausea due to chemotherapy agents used alongside IDP-023.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have multiple myeloma that has not responded to 3 or more treatments.

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I have non-Hodgkin lymphoma that didn't respond to at least 2 chemotherapy treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2)

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)

+5 more

Secondary outcome measures

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)

For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)

+2 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase 2: Combination IDP-023 plus rituximabExperimental Treatment6 Interventions

NHL patients treated with multiple doses of IDP-023 in combination with rituximab

Group II: Phase 2: Combination IDP-023 plus daratumumabExperimental Treatment6 Interventions

MM patients treated with multiple doses of IDP-023 in combination with daratumumab

Group III: Phase 1: Single Agent IDP-023 - Single DoseExperimental Treatment4 Interventions

NHL or MM patient treated with a single dose of IDP-023 monotherapy

Group IV: Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2Experimental Treatment5 Interventions

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Group V: Phase 1: Single Agent IDP-023 - Multiple DosesExperimental Treatment4 Interventions

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesna

2003

Completed Phase 2

~1380

Interleukin-2

1994

Completed Phase 3

~700

Rituximab

1999

Completed Phase 4

~1880

Daratumumab

2014

Completed Phase 3

~1990

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indapta Therapeutics, INC.Lead Sponsor

Indapta Therapeutics, Inc.Study DirectorIndapta Therapeutics, INC.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently available for this research study?

"Affirmative. Clinicaltrials.gov displays the fact that this medical study, which was initially posted on October 31st 2023, is actively recruiting participants right now. Specifically, 128 volunteers are needed from 3 separate facilities."

Answered by AI

How many applicants is the trial enrolling?

"In order to complete the study, 128 suitable participants must be identified. Indapta Therapeutics INC., are managing the trial from multiple sites such as University of Texas MD Anderson Cancer Center in Houston and NEXT Oncology Virginia located in Fairfax."

Answered by AI

What possible outcomes are being sought through this research project?

"As the primary focus of this trial, monitored for roughly 12 months, is to measure dose-limiting toxicities (DLTs), secondary objectives include evaluating pharmacokinetic profiles and anti-tumor activity. Specifically for multiple myeloma, researchers will assess objective response rate (ORR), complete response (CR) rates, stringent complete responses (sCRs), very good partial responses (VGPRs), and partial responses PR). Similarly, those with non-Hodgkin's lymphoma will have their ORRs analysed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06119685.

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