What is AVM0703 studying for lymphoid malignancies?

AVM0703 is being studied to evaluate its safety, how the body processes it, and its preliminary activity against certain blood cancers like lymphoma and leukemia. The study aims to find out if this drug can be given safely and how it affects these diseases. It is sponsored by AVM Biotechnology Inc.

Who may be eligible for this lymphoid malignancy clinical trial?

People aged 12 to 95 years with specific lymphoid cancers who have relapsed or refractory disease after prior therapies may be eligible. Both males and females can join if they meet health and lab criteria and can follow the study requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this lymphoid malignancy clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Phase 2

Age: 12Years - 95Years

All Genders

ID04329728

Open-Label Phase 12 Study of Intravenous AVM0703 for Treating Lymphoid Malignancies Including Various Lymphomas and Leukemias

Led by AVM Biotechnology Inc · Updated on 2026-04-15

144

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating AVM0703, an immunomodulatory drug given as a single intravenous infusion, in patients aged 12 to 95 years with various lymphoid malignancies, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia. This open-label Phase 12 study aims to understand its safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with relapsed or refractory disease who have undergone or are ineligible for prior therapies. The study is sponsored by AVM Biotechnology Inc.

CONDITIONS

Brief Title

The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies

Who Can Participate

Age: 12Years - 95Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 12 years or older and weight at least 40 kg
Confirmed diagnosis of specific lymphoid malignancies including DLBCL, 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, and various lymphoblastic leukemias/lymphomas
Relapsed or refractory disease after prior therapies including hematopoietic cell transplant, CAR T therapy, or multiple lines of therapy depending on diagnosis
Performance status Lansky score of 50 or higher (ages 12-15) or Karnofsky score of 50 or higher (age 16 and above)
Adequate lab values including absolute neutrophil count, platelet count, hemoglobin, liver enzymes, bilirubin, and kidney function
Pulmonary reserve with less than Grade 2 dyspnea and oxygen saturation of 92% or higher on room air
Negative pregnancy test for females of childbearing potential and agreement to use effective contraception
Ability to understand and sign informed consent and adhere to study schedule

You will not qualify if you...

History of another malignancy except certain treated skin cancers, carcinoma in situ, noninvasive bladder cancer, or cancers in remission for 2 years
Significant cardiovascular disease within 3 months prior including recent heart attack, thromboembolism, severe heart failure, or uncontrolled hypertension
Abnormal ECG findings including unstable arrhythmias, atrial fibrillation/flutter, heart blocks, bradycardia, or prolonged QT interval
Known gastric or duodenal ulcers
Uncontrolled diabetes type 1 or 2
Known allergy or hypersensitivity to AVM0703 or its components
Untreated active bacterial, fungal, or viral infections including hepatitis B or C, HIV with detectable viral load, or active tuberculosis
Received live vaccination within 8 weeks before screening
Pregnant or breastfeeding
Participation in another therapeutic clinical study except this one
Uncontrolled bipolar disorder or schizophrenia, or history of severe depression or substance abuse without prophylactic hydrocortisone treatment per protocol

Research Team

Theresa Deisher, PhD

Sandeep Mittal, PhD

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Open-Label Phase 12 Study of Intravenous AVM0703 for Treating Lymphoid Malignancies Including Various Lymphomas and Leukemias

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria