NCT04329728 · AVM Biotechnology Inc
The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
(OPAL)
What this study is about
This is an where both patients and doctors know the treatment given, Phase 1/2 study designed to characterize the safety, tolerability, how the drug moves through the body(PK), and preliminary antitumor activity of AVM0703 administered as a single given through a vein (IV) (IV) infusion to patients with lymphoid malignancies.
View original scientific description
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.
Interventions
DRUG
AVM0703
Intravenous infusion over \~1 hours
Primary outcome measures
Phase 1: incidence of Adverse events
Time frame: Year One
The primary endpoint for the Phase 1 portion of the study is the incidence of Adverse events (AEs), including DLTs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Age ≥12 years and weight ≥40 kg; 2\. 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;
- 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; 3\. 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 autolo
Where
- Duarte, California
- Los Angeles, California
- Whittier, California
- Weeki Wachee, Florida
- Chicago, Illinois
- Louisville, Kentucky
- Omaha, Nebraska
- Canton, Ohio
- Memphis, Tennessee
- Dallas, Texas
Collaborators
Medpace, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations