The OPAL Study: AVM0703 for Lymphoid Malignancies
This study, called The OPAL Study, is testing a drug called AVM0703 for people with lymphoid malignancies (cancers of the immune system). The study aims to understand how safe AVM0703 is, how well your body handles it (pharmacokinetics), and if it shows any signs of fighting cancer. You might be able to join if you are 12 to 95 years old, weigh at least 40 kg, and have a confirmed diagnosis of certain lymphoid cancers like DLBCL or MCL. The main goal for the first part of the study is to track any side effects over one year. The study is currently recruiting 144 participants, but its overall status is unclear.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving AVM0703. It is designed to enroll 144 participants.
- What's involved
- You would receive AVM0703 as an intravenous (IV) infusion over about one hour. In Phase 2, you might receive repeat infusions every 21 days until your body can't tolerate it, side effects are too severe, or your disease progresses.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety goal is measured at Year One, indicating a follow-up period of at least one year to monitor for adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04329728
The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
Recruiting
PHASE1Ages 12–95InterventionalTreatmentAVM Biotechnology Inc
~144 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:AVM0703
At a glance
Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: incidence of Adverse events
Measured over Year One
Conditions
Where it's being run
11 sites across 8 statesCalifornia4
Florida1
Illinois1
Kentucky1
Nebraska1
Ohio1
Tennessee1
Texas1
Study leadership
- Elizabeth Budde, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
- Gary Schiller, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
- Tamra Slone, MD · PRINCIPAL_INVESTIGATOR · U Texas SouthWestern
- Don Stevens, MD · PRINCIPAL_INVESTIGATOR · Norton Cancer Institute
- Lasika Seneviratne, MD · PRINCIPAL_INVESTIGATOR · Los Angeles Cancer Network
- Pamela Miel, MD · PRINCIPAL_INVESTIGATOR · Innovative Clinical Research Institute
- Stefano Tarantolo, MD · PRINCIPAL_INVESTIGATOR · Nebraska Cancer Specialists
- Daniel Kerr, MD · PRINCIPAL_INVESTIGATOR · ASCLEPES Research Centers
- Nashat Gabrail, MD · PRINCIPAL_INVESTIGATOR · Gabrail Cancer Center Research
- Paul Rubinstein, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago
- Salil Goorha, MD · PRINCIPAL_INVESTIGATOR · Memphis Baptist Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
1\. Age ≥12 years and weight ≥40 kg;
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;
DLBCL and high-grade B-cell lymphoma:
MCL:
Primary mediastinal large B-cell lymphoma: R/R after ≥1 line of therapy and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;
Primary DLBCL of the CNS: R/R after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;
Burkitt or Burkitt-like lymphoma/leukemia: R/R after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;
CLL/SLL: patients who have active disease requiring treatment and who are deemed at high-risk for disease progression by the investigator or have high risk features per the iwCLL criteria, such as primary resistance to first-line chemo(immune)therapy, or progression of disease \<3 years after fludarabine-based chemo(immune)therapy, or leukemia cells with del(17p)/TP53 mutation, must be:
Acute lymphoblastic leukemia (ALL):
B-cell lymphoblastic leukemia/lymphoma: ≥2 lines of therapy including approved CAR T cell therapies, inotuzumab ozogamicin, or blinatumomab, or for whom no standard therapy is available;
T-cell lymphoblastic leukemia/lymphoma: ≥2 lines of therapy including nelarabine, or for whom no standard therapy is available;
NK cell leukemia/lymphoma: ≥1 line of therapy or for whom no standard therapy is available;
All other diagnoses: R/R after autologous or allogeneic HCT; or R/R after at least one line of therapy, or for whom no standard therapy is available.
Absolute neutrophil count ≥0.05 × 109/L;
Platelet count ≥25 × 109/L;
Hemoglobin ≥6.5 g/dL;
• Aspartate aminotransferase or alanine aminotransferase ≥2.5 × ULN, unless due to the disease;
Total bilirubin \<1.5 × ULN (if secondary to Gilbert's syndrome, \<3 × ULN is permitted), unless due to the disease; and
Glomerular filtration rate ≥30 mL/min ; except for patients on metformin at baseline GFR must be ≥45 mL/min; GFR can be calculated by the Cockcroft-Gault formula Appendix C);
Exclusion
Patients who meet any of the following criteria will be excluded from participation in the study for Phase 2:
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; 2. 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; 3. 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; 4. Known gastric or duodenal ulcer; 5. Uncontrolled type 1 or type 2 diabetes; 6. Known hypersensitivity or allergy to the study drug or any of its excipients; 7. 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
Positive tuberculosis test during screening; test must be positive and not indeterminate due to anergy; if the result is indeterminate due to anergy the patient must not have a history of recent exposure to tuberculosis. Patients in Phase 2 repeat dosing cohorts should not travel to any destination where they might be exposed to tuberculosis during their entire treatment period with AVM0703. 8. Received live vaccination within 8 weeks of screening; 9. Pregnant or breastfeeding; 10. Concurrent participation in another therapeutic clinical study (except AVM0703-001); or 11. Uncontrolled bipolar disorder or schizophrenia. Patients with a diagnosis, past or current, of bipolar disorder or schizophrenia or having a history of severe depression or substance abuse must be prophylactically treated with circadian physiologic hydrocortisone per section 5.5.3.3 CNS prophylaxis, without exception.
What this trial measures
- Phase 1: incidence of Adverse eventsYear One
The primary endpoint for the Phase 1 portion of the study is the incidence of Adverse events (AEs), including DLTs.