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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD0120 | Experimental | AZD0120 will be administrated in one infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0120 | Biological | AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Incidence and severity of adverse events (AEs) | 2 years |
| Serious Adverse Events (SAEs) | Incidence and severity of serious adverse events (SAEs) | 2 years |
| Dose Limiting Toxicities (DLT) | Incidence of dose limiting toxicities events | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic - AUC0-28d | Area under the concentration time-curve of AZD0120 level | 0-28 Days |
| Pharmacokinetic AUC0-3M | Area under the concentration time-curve of AZD0120 level |
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Inclusion Criteria:
Age:
Type of Participant and Disease Characteristics:
For NDMM participants:
For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:
General Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Withdrawn | Phoenix | Arizona | 85054 | United States | |
| Research Site |
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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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AZD0120 will be administrated in one infusion
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| 0 - 3 Months |
| Pharmacokinetic AUClast | Area under the concentration time-curve of AZD0120 level | 2 years |
| Pharmacokinetic - Cmax | Maximum AZD0120 level | 2 years |
| Pharmacokinetic - Tmax | Time to reach Maximum AZD0120 level | 2 years |
| Pharmacokinetic - Clast | Observed concentration of AZD0120 at last quantifiable concentration | 2 years |
| Pharmacokinetic - Tlast | Time to last quantifiable concentration of AZD0120 level | 2 years |
| Pharmacokinetic - Quantification of CAR transgene levels | Determination of transgene level | 2 years |
| Efficacy - Objective Response Rate (ORR) | Defined as proportion of participants who achieve an overall response of PR or better according to the IMWG 2016 criteria | 2 years |
| Efficacy - Complete Response Rate (CRR) | Defined as proportion of participants who achieve a CR/sCR response according to the to the IMWG 2016 criteria | 2 years |
| Efficacy - Minimal Residual Disease (MRD) Negative CR Rate at 9 Months (± 3 months) | Defined as the proportion of participants with CR/sCR and MRD negative status at 9 months (± 3 months) following AZD0120 infusion | 9 months |
| Efficacy - Sustained Minimal Residual Disease (MRD) Negative CR Rate | Defined as the proportion of participants who achieve CR/sCR and maintain MRD negative status for at least 12 months with no positive MRD detected during that period | 2 years |
| Efficacy - Duration of Response (DOR) | Defined as the time from first documented confirmed response until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first | 2 years |
| Efficacy - Time to Response (TTR) | Defined as the time from infusion until the date of first documented objective response, as assessed per IMWG 2016 criteria | 2 years |
| Humoral Immunogenicity | Prevalence and incidence ADAs against AZD0120 and the impact on PK, efficacy, and safety, as data allow | 2 years |
| Module 2 Adverse Events (AEs) Maintenance | Incidence and severity of AEs for maintenance following AZD0120 infusion in participants with NDMM | 2 years |
| Module 2 Serious Adverse Events (SAEs) Maintenance | Incidence and severity of SAEs for maintenance following AZD0120 infusion in participants with NDMM | 2 years |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| Research Site | Recruiting | Denver | Colorado | 80218 | United States |
| Research Site | Recruiting | Tampa | Florida | 33612 | United States |
| Research Site | Recruiting | Atlanta | Georgia | 30322 | United States |
| Research Site | Recruiting | Iowa City | Iowa | 52242 | United States |
| Research Site | Withdrawn | Rochester | Minnesota | 55905 | United States |
| Research Site | Recruiting | St Louis | Missouri | 63110 | United States |
| Research Site | Recruiting | New York | New York | 10016 | United States |
| Research Site | Recruiting | Nashville | Tennessee | 37203 | United States |
| Research Site | Withdrawn | Dallas | Texas | 75235 | United States |
| Research Site | Recruiting | Houston | Texas | 77030 | United States |
| Research Site | Recruiting | Charlottesville | Virginia | 22903 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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