A Phase 1/2 interventional study of AZD0120 in Relapsed/Refractory Multiple Myeloma, sponsored by AstraZeneca. Recruiting at 36 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 232 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria :
Any other significant medical conditions such as:
Other protocol-defined Inclusion/Exclusion criteria apply.
AZD0120 will be administered by infusion
Biological: AZD0120
AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.
Phase 1b: Adverse Events (AEs)
The incidence and severity of AEs.
Time frame: Through study completion, a minimum of 2 years.
Phase 1b: Dose-Limiting Toxicities (DLTs)
The DLT evaluation period is defined as the first 28 days after infusion.
Time frame: 28 days
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.
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.
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.
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.
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.
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate at 12 months
Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria at 12 months.
Time frame: 12 months
Phase 1b and 2: Duration of response (DOR)
Defined among responders as the time from the date of initial documentation of an objective response (overall response of PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Time frame: Through study completion, a minimum of 2 years.
Phase 1b and 2: Progression-free survival (PFS)
Defined as the time from the date of apheresis to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Time frame: Through study completion, a minimum of 2 years.
Phase 1b and 2: Overall survival (OS)
Defined as the time from the date of apheresis to the date of the subject's death.
Time frame: Through study completion, a minimum of 2 years.
Phase 2: Adverse Events (AEs)
Further characterization of the safety of AZD0120 by measuring the incidence and severity of AEs.
Time frame: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - AUC
Area under the concentration time-curve of AZD0120 CAR transgene copies.
Time frame: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Clast
Last quantifiable AZD0120 CAR transgene copies.
Time frame: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Cmax
Maximum AZD0120 CAR transgene copies.
Time frame: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Tlast
Time to last quantifiable AZD0120 CAR transgene copies.
Time frame: Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Tmax
Time to reach maximum AZD0120 CAR transgene copies.
Time frame: Through study completion, a minimum of 2 years
Ph1b and 2: Humoral Immunogenicity
Prevalence and incidence of anti-drug antibodies (ADAs) against AZD0120 and the impact on PK, efficacy, and safety, as data allow.
Time frame: Through study completion, a minimum of 2 years.
Phase 2: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) IL355 Bone Pain and Health-Related Quality of Life Scale Scores
Change from baseline in patient-reported bone pain and health-related quality of life, as assessed using the European Organization for Research and Treatment of Cancer Item Library 355 (EORTC IL355), including the QL2 scale.
Time frame: Through study completion, a minimum of 2 years.
Phase 2: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) IL356 Physical Function and Fatigue Subscale Scores
Changes from baseline in patient-reported physical function and fatigue, as assessed using the European Organization for Research and Treatment of Cancer Item Library 356 (EORTC IL356).
Time frame: Through study completion, a minimum of 2 years.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap, Csr
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