The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies

NCT04329728 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AVM0703-001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Lymphoid Malignancies

Keywords

Diffuse large B-cell lymphoma (DLBCL); B-cell lymphoma; Mantle cell lymphoma (MCL); Primary mediastinal large B-cell Lymphoma; Primary DLBCL of the central nervous system (CNS); Burkitt or Burkitt-like lymphoma/leukemia; Chronic lymphocytic leukemia (CLL); Small lymphocytic leukemia (SLL); B-cell leukemia/lymphoma; T-cell leukemia/lymphoma; Acute leukemias of ambiguous lineage; Natural Killer (NK) cell lymphoblastic leukemia/lymphoma; Advanced or Aggressive lymphoma/lymphoproliferative disease; Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Phase 1: incidence of Adverse events

  The primary endpoint for the Phase 1 portion of the study is the incidence of Adverse events (AEs), including DLTs.

  Year One

Secondary Outcomes (1)

• Phase 2: ORR

  Year Two

Study Arms (6)

DLBCL and high-grade B-cell lymphoma

EXPERIMENTAL

Diffuse Large Cell B-Lymphoma High-grade B-cell Lymphoma

Drug: AVM0703

MCL (Chronic Lymphoid Leukemia)

EXPERIMENTAL

Chronic Lymphoid Leukemia

Drug: AVM0703

Primary Mediastinal Large B-cell lymphoma

EXPERIMENTAL

Primary mediastinal large B-cell lymphoma

Drug: AVM0703

Burkitt or Burkitt-like lymphoma/leukemia

EXPERIMENTAL

Burkitt or Burkitt-like lymphoma/leukemia

Drug: AVM0703

CLL/SLL

EXPERIMENTAL

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Drug: AVM0703

B- or T-ALL

EXPERIMENTAL

B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or natural killer (NK) cell lymphoblastic leukemia/lymphoma

Drug: AVM0703

Interventions

AVM0703 DRUG

Intravenous infusion over \~1 hours

Also known as: Supra-Pharmacologic Dexamethasone Phosphate

B- or T-ALL; Burkitt or Burkitt-like lymphoma/leukemia; CLL/SLL; DLBCL and high-grade B-cell lymphoma; MCL (Chronic Lymphoid Leukemia); Primary Mediastinal Large B-cell lymphoma

Eligibility Criteria

• Age: 12 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥12 years and weight ≥40 kg;
• \. Histologically confirmed diagnosis per 2016 World Health Organization (WHO) classification of lymphoid neoplasms160 and per the 2016 WHO classification of acute leukemia161 of the following indications:
• DLBCL, including arising from follicular lymphoma;
• High-grade B-cell lymphoma;
• MCL;
• Primary mediastinal large B-cell lymphoma;
• Primary DLBCL of the CNS;
• Burkitt or Burkitt-like lymphoma/leukemia;
• CLL/SLL; or
• B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or NK cell lymphoblastic leukemia/lymphoma;
• \. Patients must have relapsed or refractory (R/R) disease with prior therapies defined below:
• DLBCL and high-grade B-cell lymphoma:
• e) R/R after autologous hematopoietic cell transplant (HCT); or f) R/R after chimeric antigen receptor T-cell (CAR T) therapy; or g) Patients not eligible for autologous HCT or CAR T therapy; or h) R/R after ≥2 lines of therapy including anti-CD20 antibody and failed, intolerant or ineligible for polatuzamab vedotin, or for whom no standard therapy is available.
• MCL:
• c) R/R after autologous HCT; or d) Patients not eligible for autologous HCT must have failed acalabrutinib or be R/R after ≥2 lines of therapy including at least 1 of the following: a Bruton's tyrosine kinase (BTK) inhibitor, bortezomib, or lenalidomide; or for whom no standard therapy is available;

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from participation in the study for Phase 2:
• History of another malignancy, except for the following:
• Adequately treated local basal cell or squamous cell carcinoma of the skin;
• Adequately treated carcinoma in situ without evidence of disease;
• Adequately treated papillary, noninvasive bladder cancer; or
• Other cancer that has been in complete remission for ≥2 years. Patients with low-grade prostate cancer, on active surveillance, and not expected to clinically progress over 2 years are allowed;
• Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start of AVM0703 administration, angina requiring therapy, symptomatic peripheral vascular disease, New York Heart Association Class III or IV congestive heart failure, left ventricular ejection fraction \<30%, left ventricular fractional shortening \<20%, or uncontrolled ≥Grade 3 hypertension (diastolic blood pressure \>100 mmHg or systolic blood pressure \>150 mmHg) despite antihypertensive therapy for patients ≥18 years of age, or uncontrolled stage 2 hypertension (diastolic blood pressure \>90 mmHg or systolic blood pressure \>140 mmHg) despite antihypertensive therapy for patients ≥12 years of age;
• Significant screening electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation/flutter, second degree atrioventricular (AV) block type 2, third-degree AV block, ≥Grade 2 bradycardia, or heart rate corrected QT interval using Fridericia's formula \>480 msec;
• Known gastric or duodenal ulcer;
• Uncontrolled type 1 or type 2 diabetes;
• Known hypersensitivity or allergy to the study drug or any of its excipients;
• Untreated ongoing bacterial, fungal, or viral infection (including upper respiratory tract infections) at the start of AVM0703 administration, including the following:
• Positive hepatitis B surface antigen and/or hepatitis B core antibody test plus a positive hepatitis B polymerase chain reaction (PCR) assay. Patients with a negative PCR assay are permitted with appropriate antiviral prophylaxis;
• Positive hepatitis C virus antibody (HCV Ab) test. Patients with a positive HCV Ab test are eligible if they are negative for hepatitis C virus by PCR;
• Positive human immunodeficiency virus (HIV) antibody test with detectable HIV load by PCR, or the patient is not able to tolerate antiretroviral therapy; or

Sponsors & Collaborators

• AVM Biotechnology Inc: lead
• Medpace, Inc.: collaborator

Study Sites (11)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Los Angeles Cancer Network

Los Angeles, California, 90017, United States

RECRUITING

UCLA Medical Center of Hematology/Oncology

Los Angeles, California, 90095, United States

RECRUITING

Innovative Clinical Research Institute

Whittier, California, 92705, United States

RECRUITING

ASCLEPES Research Centers

Weeki Wachee, Florida, 34613, United States

RECRUITING

University of Illinois at Chicago Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

RECRUITING

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68124, United States

RECRUITING

Gabrail Cancer Center Research,

Canton, Ohio, 44718, United States

RECRUITING

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

RECRUITING

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

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, B-Cell; Lymphoma; Leukemia, T-Cell; Leukemia, Biphenotypic, Acute; Lymphoproliferative Disorders; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Budde, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

• Gary Schiller, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Tamra Slone, MD

  U Texas SouthWestern

  PRINCIPAL INVESTIGATOR

• Don Stevens, MD

  Norton Cancer Institute

  PRINCIPAL INVESTIGATOR

• Lasika Seneviratne, MD

  Los Angeles Cancer Network

  PRINCIPAL INVESTIGATOR

• Pamela Miel, MD

  Innovative Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Stefano Tarantolo, MD

  Nebraska Cancer Specialists

  PRINCIPAL INVESTIGATOR

• Daniel Kerr, MD

  ASCLEPES Research Centers

  PRINCIPAL INVESTIGATOR

• Nashat Gabrail, MD

  Gabrail Cancer Center Research

  PRINCIPAL INVESTIGATOR

• Paul Rubinstein, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Salil Goorha, MD

  Memphis Baptist Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Deisher, PhD

CONTACT

206-851-3942; tdeisher@avmbiotech.com

Sandeep Mittal, PhD

CONTACT

346-401-4303; smittal@avmbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: April 1, 2020
• Study Start: November 6, 2020
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)