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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.

Must not have

Active SARS-CoV-2 infection.

Impaired cardiac function or history of clinical significant cardiac disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests IDP-023, a treatment using special immune cells to fight cancer, in patients with advanced multiple myeloma or non-Hodgkin's lymphoma who haven't responded to other treatments. IDP-023 is part of a broader category of immunotherapies that have shown promise in treating multiple myeloma and non-Hodgkin's lymphoma.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently infected with COVID-19.

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I have heart problems or a history of significant heart disease.

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I have HIV, active hepatitis B, or hepatitis C.

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I have untreated brain or spinal cord tumor spread.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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