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AVM0703 for Lymphoma (OPAL Trial)

Phase 1 & 2

Recruiting

Led By Michaela Tsai, MD

Research Sponsored by AVM Biotechnology Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have relapsed or refractory (R/R) disease with prior therapies defined

Lansky (12 to 15 years of age) or Karnofsky (≥16 years of age) performance status ≥50

Must not have

Received live vaccination within 8 weeks of screening

Uncontrolled type 1 or type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year two

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new cancer treatment to determine if it is safe and effective.

Who is the study for?

This trial is for people aged 12 and older, weighing more than 40 kg, with certain types of lymphoid malignancies that have not responded to previous treatments or who cannot receive them due to various reasons. Participants need a minimum level of physical health and organ function, must not be pregnant or breastfeeding, and agree to use contraception.

What is being tested?

The OPAL Study is testing AVM0703 as a single IV infusion for patients with lymphoid malignancies. It's an open-label study which means everyone knows what treatment they're getting. The focus is on safety, how the body processes the drug (pharmacokinetics), tolerability, and initial effectiveness against tumors.

What are the potential side effects?

While specific side effects are not listed here, common ones from similar trials may include reactions at the infusion site, fatigue, fever, nausea or vomiting. Since it's a Phase 1/2 study focusing on safety and tolerability; monitoring for any adverse effects will be a key part of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition did not improve or worsened after previous treatments.

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I can do most activities but may need help.

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I am 12 years or older and weigh at least 40 kg.

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I am mostly able to carry on with normal activities or take care of myself.

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My cancer is one of the specific types listed by the WHO.

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I can understand and am willing to sign the consent form and follow the study rules.

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I am not pregnant and will use effective birth control during and after the study.

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I don't have severe shortness of breath and my oxygen level is above 92% without assistance.

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My cancer is one of the specific types listed by the WHO.

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I am 12 years or older and weigh more than 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a live vaccine in the last 8 weeks.

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My diabetes is not well-managed.

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I do not have any untreated infections.

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I have been diagnosed with a stomach or duodenal ulcer.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year one

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year one

This trial's timeline: 3 weeks for screening, Varies for treatment, and year one for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: incidence of Adverse events

Secondary study objectives

Phase 2: ORR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Primary Mediastinal Large B-cell lymphomaExperimental Treatment1 Intervention

Primary mediastinal large B-cell lymphoma

Group II: MCL (Chronic Lymphoid Leukemia)Experimental Treatment1 Intervention

Chronic Lymphoid Leukemia

Group III: DLBCL and high-grade B-cell lymphomaExperimental Treatment1 Intervention

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

Group IV: CLL/SLLExperimental Treatment1 Intervention

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Group V: Burkitt or Burkitt-like lymphoma/leukemiaExperimental Treatment1 Intervention

Burkitt or Burkitt-like lymphoma/leukemia

Group VI: B- or T-ALLExperimental Treatment1 Intervention

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

0 / 15Eligibility criteria met