A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)
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: 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 Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)
Overview
This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).
Detailed description
This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1 consists of early line MM (including newly diagnosed MM and early relapsed or primary refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ± maintenance.
Interventions
- Biological AZD0120
AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma
Primary outcome measures
- Adverse Events (AEs) [Time frame: 2 years]
- Serious Adverse Events (SAEs) [Time frame: 2 years]
- Dose Limiting Toxicities (DLT) [Time frame: 28 days]
Secondary outcome measures (12)
- Pharmacokinetic - AUC0-28d [Time frame: 0-28 Days]
- Pharmacokinetic AUC0-3M [Time frame: 0 - 3 Months]
- Pharmacokinetic AUClast [Time frame: 2 years]
- Pharmacokinetic - Cmax [Time frame: 2 years]
- Pharmacokinetic - Tmax [Time frame: 2 years]
- Pharmacokinetic - Clast [Time frame: 2 years]
- Pharmacokinetic - Tlast [Time frame: 2 years]
- Pharmacokinetic - Quantification of CAR transgene levels [Time frame: 2 years]
- Efficacy - Objective Response Rate (ORR) [Time frame: 2 years]
- Efficacy - Complete Response Rate (CRR) [Time frame: 2 years]
- Efficacy - Minimal Residual Disease (MRD) Negative CR Rate at 9 Months (± 3 months) [Time frame: 9 months]
- Efficacy - Sustained Minimal Residual Disease (MRD) Negative CR Rate [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
Age:
- Males and females ≥18 years of age at the time of consent
Type of Participant and Disease Characteristics:
- Participant must have documented diagnosis of MM per IMWG diagnostic criteria
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function.
For NDMM participants:
- Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
- For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening
- Classified as high-risk MM
For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:
- Have received and failed 1 or 2 lines of anti-myeloma therapy
- Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
- Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen
General Exclusion Criteria:
- Have received prior treatment with CAR T therapy directed at any target
- Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
- Active or history of plasma cell leukemia at the time of screening
- Seropositive for human immunodeficiency virus (HIV)
- Active Hepatitis B infection
- Active Hepatitis C infection
- Serious underlying medical condition
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 · 13 centers
- Research Site — Phoenix
- Research Site — Duarte
- Research Site — Denver
- Research Site — Tampa
- Research Site — Atlanta
- Research Site — Iowa City
- Research Site — Rochester
- Research Site — St Louis
- … and 5 more centers
Identifiers
NCT: NCT07073547 · D831EC00001