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OncoMatch/Clinical Trials/NCT04594642

A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma

Is NCT04594642 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies AZD0486 IV for b-cell non hodgkin lymphoma.

Phase 1RecruitingAstraZenecaNCT04594642Data as of Jun 2026Location: International · 5 countries

Treatment: AZD0486 IVThis phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).

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Extracted eligibility criteria

Treatments studied

Other

AZD0486 IV

Cancer type

Non-Hodgkin Lymphoma

Diffuse Large B-Cell Lymphoma

Biomarker criteria

Required: CD19 positive

Subject must have locally confirmed CD19 positivity (must be documented after time of progression from last CD19-targeted therapy, if received)

Disease stage

Required: Stage II, III, IV

Grade: 123a (who 2016)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 130

Prior therapy

Min 2 prior lines

Cannot have received: CD19 CAR T cell therapy

Exception: CAR T-naive subjects are allowed if they have declined, are considered ineligible for, or do not have timely access to CAR T cell therapies

CAR T-naive subjects are allowed if they have declined, are considered ineligible for, or do not have timely access to CAR T cell therapies.

Cannot have received: CD19 CAR T cell therapy

Subject received CD19 CAR T therapy within 3 months prior to first dose.

Cannot have received: peripheral autologous stem cell transplant

Subject has received a peripheral autologous stem cell transplant (SCT) within 12 weeks

Cannot have received: allogeneic stem cell transplant

an allogeneic SCT within 1 year of the first dose of study drug treatment

Cannot have received: stem cell transplant

Exception: requires ongoing immunosuppressive therapy

has received an SCT and requires ongoing immunosuppressive therapy

Lab requirements

Blood counts

anc ≥ 1000/mm3, platelets ≥ 50,000 mm3, hemoglobin ≥ 8.0 g/dl

Kidney function

egfr ≥ 50 ml/min

Liver function

total bilirubin <1.5x uln, ast/alt < 3xuln

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

US trial sites

  • Research Site · Tampa, Florida
  • Research Site · Louisville, Kentucky
  • Research Site · New Brunswick, New Jersey
  • Research Site · Charlotte, North Carolina
  • Research Site · Columbus, Ohio

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT04594642 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CD19 CAR T cell therapy, CD19 CAR T cell therapy, peripheral autologous stem cell transplant disqualifies patients from enrollment.

Does this trial require CD19?

Yes, CD19 positive is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or III or IV is required.

Is there an age limit?

Yes. Patients must be 130 years or younger.

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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