AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

Официальное название

A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат AZD0120
  AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.

Первичные конечные точки

• Phase 1b: Adverse Events (AEs) [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 1b: Dose-Limiting Toxicities (DLTs) [Срок оценки: 28 days]
• Phase 2: Objective Response Rate (ORR) [Срок оценки: Through study completion, a minimum of 2 years.]

Вторичные конечные точки (12)

• Phase 1b and 2: Complete response rate (CRR) [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 1b and 2: Time to response (TTR) [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 1b: Objective Response Rate (ORR) [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate at 12 months [Срок оценки: 12 months]
• Phase 1b and 2: Duration of response (DOR) [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 1b and 2: Progression-free survival (PFS) [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 1b and 2: Overall survival (OS) [Срок оценки: Through study completion, a minimum of 2 years.]
• Phase 2: Adverse Events (AEs) [Срок оценки: Through study completion, a minimum of 2 years.]
• Ph1b and 2: Pharmacokinetics - AUC [Срок оценки: Through study completion, a minimum of 2 years.]
• Ph1b and 2: Pharmacokinetics - Clast [Срок оценки: Through study completion, a minimum of 2 years.]
• Ph1b and 2: Pharmacokinetics - Cmax [Срок оценки: Through study completion, a minimum of 2 years.]

Критерии участия

Критерии включения

• ≥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.
• Have documented evidence of progressive disease per IMWG criteria.
• Participant must have measurable disease at screening.
• Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.

Критерии исключения

• 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.
• Any other significant medical conditions such as:

• Serious active or uncontrolled infection
• Active autoimmune disease or a history of autoimmune disease within 2 years
• Active plasma cell leukemia at the time of screening
• Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
• Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.

Other protocol-defined Inclusion/Exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 36 центров

• Research Site — Birmingham
• Research Site — Phoenix
• Research Site — La Jolla
• Research Site — Los Angeles
• Research Site — San Francisco
• Research Site — Aurora
• Research Site — Denver
• Research Site — Jacksonville
• … и ещё 28 центров

Идентификаторы

NCT: NCT05850234 · D8310C00001 · GC012F-CD19/BCMA-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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