AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
ConditionRelapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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.
Serious active or uncontrolled infection
Trial design
Design model
Single group
Treatments tested in this trial
AZD0120
Biological/VaccineAZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.
Treatment groups
232 Participants
are divided into 1 treatment groupGroup A: AZD0120Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1b: Adverse Events (AEs)
The incidence and severity of AEs.
Time frame
Through study completion, a minimum of 2 years.2
Phase 1b: Dose-Limiting Toxicities (DLTs)
The DLT evaluation period is defined as the first 28 days after infusion.
Time frame
28 days3
Phase 2: Objective Response Rate (ORR)
Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.
Time frame
Through study completion, a minimum of 2 years.Secondary outcomes
1
Phase 1b and 2: Complete response rate (CRR)
Defined as the proportion of participants who achieved complete response (CR) or better per International Myeloma Working Group (IMWG) criteria.
Time frame
Through study completion, a minimum of 2 years.2
Phase 1b and 2: Time to response (TTR)
Defined as the time between date of apheresis and the first efficacy evaluation that the participant has met all criteria for partial response (PR) or better.
Time frame
Through study completion, a minimum of 2 years.3
Phase 1b: Objective Response Rate (ORR)
Defined as the proportion of participants who achieved PR or better by IMWG response criteria.
Time frame
Through study completion, a minimum of 2 years.4
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate
Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria.
Time frame
Through study completion, a minimum of 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov