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)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females ≥18 years of age at the time of consent

Participant must have documented diagnosis of MM per IMWG diagnostic criteria

ECOG performance status of 0 or 1.

Adequate organ and bone marrow function.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • AZD0120

    Biological/Vaccine

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: AZD0120Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AEs)

Incidence and severity of adverse events (AEs)

Time frame
2 years
2

Serious Adverse Events (SAEs)

Incidence and severity of serious adverse events (SAEs)

Time frame
2 years
3

Dose Limiting Toxicities (DLT)

Incidence of dose limiting toxicities events

Time frame
28 days

Secondary outcomes

1

Pharmacokinetic - AUC0-28d

Area under the concentration time-curve of AZD0120 level

Time frame
0-28 Days
2

Pharmacokinetic AUC0-3M

Area under the concentration time-curve of AZD0120 level

Time frame
0 - 3 Months
3

Pharmacokinetic AUClast

Area under the concentration time-curve of AZD0120 level

Time frame
2 years
4

Pharmacokinetic - Cmax

Maximum AZD0120 level

Time frame
2 years

Other outcomes

Sponsors and contacts

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