RecruitingPhase 1Phase 2NCT04329728

The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies

An Open Label, Phase 1/2 Study Evaluating Immunomodulatory AVM0703 in Patients With Lymphoid Malignancies (OPAL Study)


Sponsor

AVM Biotechnology Inc

Enrollment

144 participants

Start Date

Nov 6, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, Phase 1/2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.


Eligibility

Min Age: 12 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AVM0703 for people with certain types of blood cancers (B-cell lymphomas, leukemias, and related conditions) that have come back or are no longer responding to prior treatments, including stem cell transplant or CAR T-cell therapy. AVM0703 works differently from standard treatments by activating a specific type of immune cell. **You may be eligible if...** - You are 12 years or older and weigh at least 40 kg (about 88 lbs) - You have a confirmed diagnosis of a specific type of lymphoma or leukemia (including DLBCL, high-grade B-cell lymphoma, mantle cell lymphoma, Burkitt lymphoma, CLL, or acute leukemia) - Your cancer has come back or stopped responding after prior therapies, including CAR T-cell therapy or stem cell transplant - Standard treatments are no longer effective or available for you **You may NOT be eligible if...** - You have not yet tried standard treatments for your type of lymphoma - Your cancer type is not included in the study - You have conditions that could interfere with the study treatment or evaluation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAVM0703

Intravenous infusion over \~1 hours


Locations(11)

City of Hope

Duarte, California, United States

Los Angeles Cancer Network

Los Angeles, California, United States

UCLA Medical Center of Hematology/Oncology

Los Angeles, California, United States

Innovative Clinical Research Institute

Whittier, California, United States

ASCLEPES Research Centers

Weeki Wachee, Florida, United States

University of Illinois at Chicago Cancer Center

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Gabrail Cancer Center Research,

Canton, Ohio, United States

Baptist Clinical Research Institute

Memphis, Tennessee, United States

University of Texas(UT) Southwestern-Children's Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04329728


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