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OncoMatch/Clinical Trials/NCT04329728

The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies

Is NCT04329728 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies AVM0703 for lymphoid malignancies.

Phase 1/2RecruitingAVM Biotechnology IncNCT04329728Data as of Jun 2026

Treatment: AVM0703This 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.

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Extracted eligibility criteria

Treatments studied

Other

AVM0703

Demographics

Ages 12–95

Prior therapy

Must have received: autologous hematopoietic cell transplant — relapsed/refractory

R/R after autologous hematopoietic cell transplant (HCT)

Must have received: CAR-T cell therapy — relapsed/refractory

R/R after chimeric antigen receptor T-cell (CAR T) therapy

Must have received: anti-CD20 antibody — relapsed/refractory

R/R after ≥2 lines of therapy including anti-CD20 antibody and failed, intolerant or ineligible for polatuzamab vedotin

Must have received: Bruton's tyrosine kinase (BTK) inhibitor (acalabrutinib) — relapsed/refractory

failed acalabrutinib or be R/R after ≥2 lines of therapy including at least 1 of the following: a Bruton's tyrosine kinase (BTK) inhibitor, bortezomib, or lenalidomide

Must have received: bortezomib (bortezomib) — relapsed/refractory

R/R after ≥2 lines of therapy including at least 1 of the following: a Bruton's tyrosine kinase (BTK) inhibitor, bortezomib, or lenalidomide

Must have received: lenalidomide (lenalidomide) — relapsed/refractory

R/R after ≥2 lines of therapy including at least 1 of the following: a Bruton's tyrosine kinase (BTK) inhibitor, bortezomib, or lenalidomide

Must have received: methotrexate (methotrexate) — relapsed/refractory

R/R after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate)

Must have received: venetoclax (venetoclax) — relapsed/refractory

R/R after ≥2 lines of therapy including at least 1 of the following: a BTK inhibitor, venetoclax, idelalisib, or duvelisib

Must have received: idelalisib (idelalisib) — relapsed/refractory

R/R after ≥2 lines of therapy including at least 1 of the following: a BTK inhibitor, venetoclax, idelalisib, or duvelisib

Must have received: duvelisib (duvelisib) — relapsed/refractory

R/R after ≥2 lines of therapy including at least 1 of the following: a BTK inhibitor, venetoclax, idelalisib, or duvelisib

Must have received: allogeneic hematopoietic cell transplant — relapsed/refractory

R/R after allogeneic HCT

Must have received: inotuzumab ozogamicin (inotuzumab ozogamicin) — relapsed/refractory

≥2 lines of therapy including approved CAR T cell therapies, inotuzumab ozogamicin, or blinatumomab

Must have received: blinatumomab (blinatumomab) — relapsed/refractory

≥2 lines of therapy including approved CAR T cell therapies, inotuzumab ozogamicin, or blinatumomab

Must have received: nelarabine (nelarabine) — relapsed/refractory

≥2 lines of therapy including nelarabine

Lab requirements

Blood counts

Absolute neutrophil count ≥0.05 × 10^9/L; Platelet count ≥25 × 10^9/L; Hemoglobin ≥6.5 g/dL

Kidney function

Glomerular filtration rate ≥30 mL/min; except for patients on metformin at baseline GFR must be ≥45 mL/min

Liver function

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

Cardiac function

Minimum level of pulmonary reserve defined as <Grade 2 dyspnea and pulse oximetry ≥92% on room air

Screening laboratory values that meet all of the following criteria: ... Minimum level of pulmonary reserve defined as <Grade 2 dyspnea and pulse oximetry ≥92% on room air

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope · Duarte, California
  • Los Angeles Cancer Network · Los Angeles, California
  • UCLA Medical Center of Hematology/Oncology · Los Angeles, California
  • Innovative Clinical Research Institute · Whittier, California
  • ASCLEPES Research Centers · Weeki Wachee, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT04329728 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received autologous hematopoietic cell transplant and CAR-T cell therapy.

Is there an age limit?

Yes. Patients must be 95 years or younger and at least 12 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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