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Recruiting Phase 1/2

AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

NCT05850234 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2023-07-20
Last updated
2026-10-08

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

AZD0120 →

AZD0120: AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.

Study summary

This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * ≥18 years of age at the time of consent. * ECOG performance status of 0 or 1. * Documented diagnosis of MM per IMWG diagnostic criteria. * Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody. * Have documented evidence of progressive disease per IMWG criteria. * Participant must have measurable disease at screening. * Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening. Exclusion Criteria : * Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy. * Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply. * Participant has significant cardiac, neurological, or psychiatric conditions. * Any other significant medical conditions such as: * Serious active or uncontrolled infection * Active autoimmune disease or a history of autoimmune disease within 2 years * Active plasma cell leukemia at the time of screening * Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF). * Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM. Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Phase 1b: Adverse Events (AEs) — Through study completion, a minimum of 2 years.
    The incidence and severity of AEs.
  • Phase 1b: Dose-Limiting Toxicities (DLTs) — 28 days
    The DLT evaluation period is defined as the first 28 days after infusion.
  • Phase 2: Objective Response Rate (ORR) — Through study completion, a minimum of 2 years.
    Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.

Trial sites (36)

FacilityCityRegionStatus
Research Site Birmingham Alabama Recruiting
Research Site Phoenix Arizona Recruiting
Research Site La Jolla California Recruiting
Research Site Los Angeles California Recruiting
Research Site San Francisco California Recruiting
Research Site Aurora Colorado Recruiting
Research Site Denver Colorado Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Tampa Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Chicago Illinois Recruiting
Research Site Iowa City Iowa Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Ann Arbor Michigan Recruiting
Research Site Detroit Michigan Recruiting
Research Site Minneapolis Minnesota Recruiting
Research Site Rochester Minnesota Recruiting
Research Site Omaha Nebraska Withdrawn
Research Site Hackensack New Jersey Withdrawn
Research Site Buffalo New York Withdrawn
Research Site New York New York Recruiting
Research Site Stony Brook New York Recruiting
Research Site Charlotte North Carolina Recruiting
Research Site Durham North Carolina Recruiting
Research Site Nashville Tennessee Recruiting
Research Site Nashville Tennessee Recruiting
Research Site Austin Texas Recruiting
Research Site Dallas Texas Recruiting
Research Site Houston Texas Recruiting
Research Site Salt Lake City Utah Recruiting
Research Site Charlottesville Virginia Recruiting
Research Site Edmonds Washington Recruiting
Research Site Seattle Washington Recruiting
Research Site Milwaukee Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05850234 on ClinicalTrials.gov ↗ ← All trials in the USA