Menu
Recruiting NCT05850234

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

Phase I / Phase II Interventional Relapsed/Refractory Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AZD0120.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Phase 1b: Adverse Events (AEs) [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 1b: Dose-Limiting Toxicities (DLTs) [Time frame: 28 days]
  • Phase 2: Objective Response Rate (ORR) [Time frame: Through study completion, a minimum of 2 years.]
Secondary outcome measures (12)
  • Phase 1b and 2: Complete response rate (CRR) [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 1b and 2: Time to response (TTR) [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 1b: Objective Response Rate (ORR) [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate at 12 months [Time frame: 12 months]
  • Phase 1b and 2: Duration of response (DOR) [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 1b and 2: Progression-free survival (PFS) [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 1b and 2: Overall survival (OS) [Time frame: Through study completion, a minimum of 2 years.]
  • Phase 2: Adverse Events (AEs) [Time frame: Through study completion, a minimum of 2 years.]
  • Ph1b and 2: Pharmacokinetics - AUC [Time frame: Through study completion, a minimum of 2 years.]
  • Ph1b and 2: Pharmacokinetics - Clast [Time frame: Through study completion, a minimum of 2 years.]
  • Ph1b and 2: Pharmacokinetics - Cmax [Time frame: Through study completion, a minimum of 2 years.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 36 centers
  • Research Site — Birmingham
  • Research Site — Phoenix
  • Research Site — La Jolla
  • Research Site — Los Angeles
  • Research Site — San Francisco
  • Research Site — Aurora
  • Research Site — Denver
  • Research Site — Jacksonville
  • … and 28 more centers

Identifiers

NCT: NCT05850234 · D8310C00001 · GC012F-CD19/BCMA-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗