Actively Recruiting
The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
Led by AVM Biotechnology Inc · Updated on 2026-04-15
144
Participants Needed
11
Research Sites
421 weeks
Total Duration
On this page
Sponsors
A
AVM Biotechnology Inc
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older and weight at least 40 kg
- Histologically confirmed lymphoid malignancy as defined by WHO classification, including DLBCL (including from follicular lymphoma), high-grade B-cell lymphoma, mantle cell lymphoma, primary mediastinal large B-cell lymphoma, primary DLBCL of the CNS, Burkitt or Burkitt-like lymphoma/leukemia, CLL/SLL, or various acute lymphoblastic leukemias/lymphomas
- Relapsed or refractory disease after prior therapies including autologous or allogeneic hematopoietic cell transplant, CAR T-cell therapy, or multiple lines of treatment as specified for each lymphoma type
- Lansky (for ages 12-15) or Karnofsky (for 16 and older) performance status of 50 or higher
- Laboratory values meeting specified minimums including neutrophil count, platelet count, hemoglobin, liver enzymes, bilirubin, and kidney function
- Pulmonary reserve defined as less than Grade 2 dyspnea and pulse oximetry 92% or higher on room air
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception during and one month after study treatment
- Ability to understand and sign informed consent (and assent if under 18), and willingness to follow study schedule and rules
You will not qualify if you...
- History of another malignancy except adequately treated local skin cancers, carcinoma in situ, certain bladder cancers, or other cancers in remission for at least 2 years; low-grade prostate cancer on active surveillance is allowed
- Significant cardiovascular disease within 3 months prior to study including recent heart attack, thromboembolism, symptomatic peripheral vascular disease, severe heart failure, or uncontrolled hypertension despite treatment
- Abnormal screening ECG including unstable arrhythmias, atrial fibrillation/flutter, advanced heart block, significant bradycardia, or prolonged QT interval
- Known gastric or duodenal ulcers
- Uncontrolled type 1 or type 2 diabetes
- Known allergy or hypersensitivity to AVM0703 or its components
- Untreated infections including active hepatitis B or C (with specific criteria), HIV with detectable viral load or intolerance to therapy, or positive tuberculosis test without appropriate history or prophylaxis
- Received live vaccines within 8 weeks before screening
- Pregnant or breastfeeding
- Participation in another therapeutic clinical study (except AVM0703-001)
- Uncontrolled bipolar disorder or schizophrenia or history of severe depression or substance abuse without appropriate hydrocortisone prophylaxis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Los Angeles Cancer Network
Los Angeles, California, United States, 90017
Actively Recruiting
3
UCLA Medical Center of Hematology/Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
4
Innovative Clinical Research Institute
Whittier, California, United States, 92705
Actively Recruiting
5
ASCLEPES Research Centers
Weeki Wachee, Florida, United States, 34613
Actively Recruiting
6
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
7
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
8
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68124
Actively Recruiting
9
Gabrail Cancer Center Research,
Canton, Ohio, United States, 44718
Actively Recruiting
10
Baptist Clinical Research Institute
Memphis, Tennessee, United States, 38120
Actively Recruiting
11
University of Texas(UT) Southwestern-Children's Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
T
Theresa Deisher, PhD
CONTACT
S
Sandeep Mittal, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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