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)

Phase 1RecruitingNCT07073547

AstraZeneca40 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

AZD0120BIOLOGICAL

AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Research Site

Phoenix, Arizona, United States

WITHDRAWN

Research Site

Duarte, California, United States

RECRUITING

Outcomes

Primary Outcomes

Adverse Events (AEs)

Incidence and severity of adverse events (AEs)

Time frame: 2 years

Serious Adverse Events (SAEs)

Incidence and severity of serious adverse events (SAEs)

Time frame: 2 years

Dose Limiting Toxicities (DLT)

Incidence of dose limiting toxicities events

Time frame: 28 days

Secondary Outcomes

Pharmacokinetic - AUC0-28d

Area under the concentration time-curve of AZD0120 level

Time frame: 0-28 Days

Pharmacokinetic AUC0-3M

Area under the concentration time-curve of AZD0120 level

Time frame: 0 - 3 Months

Pharmacokinetic AUClast

Area under the concentration time-curve of AZD0120 level

Time frame: 2 years

Pharmacokinetic - Cmax

Maximum AZD0120 level

Time frame: 2 years

Pharmacokinetic - Tmax

Time to reach Maximum AZD0120 level

Time frame: 2 years

Pharmacokinetic - Clast

Observed concentration of AZD0120 at last quantifiable concentration

Time frame: 2 years

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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