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

AstraZeneca

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Relapsed/Refractory Multiple Myeloma

Treatments: Biological: AZD0120

Study type: Interventional

Funder types: Industry

Identifiers

NCT05850234

D8310C00001

GC012F-CD19/BCMA-001

Details and patient eligibility

About

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.

Full description

Phase 1b aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, and immunogenicity in subjects with relapsed/refractory multiple myeloma and determine the recommended Phase 2 dose of AZD0120.

Phase II aims to evaluate the efficacy of AZD0120, and to further characterize the safety, pharmacodynamic effects, immunogenicity, and changes in health-related quality of life parameters in subjects with relapsed/refractory multiple myeloma.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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182 participants in 1 patient group

AZD0120

Experimental group

Description:

AZD0120 will be administered by infusion

Treatment:

Biological: AZD0120