베타
임상 레이더 AI
임상시험 NCT06542250 (TITANium)은(는) B 세포 악성 종양에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
검색으로 돌아가기

A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. (TITANium) 1상, 2상 174

모집중
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06542250 (TITANium)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 B 세포 악성 종양에 대해 진행되며, 1상 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 9월 18일에 시작되어 174명의 참여자를 모집하고 있습니다. 아스트라제네카이(가) 진행하며, 2028년 2월 14일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
공식 제목

A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)

질환명
B 세포 악성 종양
기타 연구 식별자
  • TITANium
  • D9960C00001
NCT 번호
NCT06542250
실제 연구 시작일
2024-09-18
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2028-02-14
계획된 등록 인원
174
연구종류
중재연구
단계/상
1상
2상
상태
모집중
키워드
CD20
CD8
T cell engager
TCR
AZD5492
Relapsed, Refractory
B-cell malignancies
CLL, Chronic lymphocytic leukemia
SLL, Small lymphocytic lymphoma
MCL, Mantle cell lymphoma
LBCL, Large B-cell lymphoma
FL, Follicular lymphoma
TITANium
TCE
주요 목적
치료
설계 할당
해당 없음
중재 모델
순차설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Module 1: AZD5492 Monotherapy
AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.
AZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
주요결과변수
결과변수측정값 설명시간 범위
Frequency of dose limiting toxicities (DLTs).
DLTs are dose-limiting toxicities as defined in the study protocol.
Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).
Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.
Incidence and severity of AEs, AESIs, and SAEs
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.
SAEs/AEs leading to discontinuation of AZD5492.
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
이차결과변수
결과변수측정값 설명시간 범위
Overall Response Rate (ORR)
The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Complete Response Rate (CR Rate)
The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Duration of Response (DoR)
The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Progression-free Survival (PFS)
The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Overall Survival (OS)
The time from the date of first dose until date of death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Pharmacokinetics of AZD5492: serum concentration of study drug
Maximum observed serum concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax).
Maximum observed plasma concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC).
Area under the plasma concentration-time curve.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: apparent clearance
The volume of plasma from which the study drug is completely removed per unit time.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Half-life (t 1/2)
Terminal elimination half-life.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The number of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The percentage of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체

  • ≥18 years of age;

  • Histologically documented CD20+ mature B-cell neoplasm

    • Large B-cell lymphoma
    • Follicular lymphoma
    • Mantle cell lymphoma
    • Chronic lymphocytic leukemia
    • Small lymphocytic lymphoma

  • Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;

  • ECOG performance status of ≤ 2 (< 2 in EU countries).

The above is a summary, other inclusion criteria details may apply.

  • Any neoplasm histology not specified in the IC section;
  • Active CNS involvement in lymphoma;
  • CNS pathology including but not limited to any history of seizure disorder/epilepsy;
  • Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
  • History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
  • Active and uncontrolled infections;
  • Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions

The above is a summary, other exclusion criteria details may apply.

AstraZeneca logo아스트라제네카772개의 진행 중인 임상시험 탐색 가능
연구 대표 연락처
연락처: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
29 10개국에 임상시험 장소

California

Research Site, La Jolla, California, 92093, United States
모집중

Massachusetts

Research Site, Boston, Massachusetts, 02215, United States
철회

New Jersey

Research Site, Hackensack, New Jersey, 07601, United States
모집중

New York

Research Site, New York, New York, 10021, United States
모집중
Research Site, New York, New York, 10029, United States
모집중

North Carolina

Research Site, Charlotte, North Carolina, 28203, United States
모집중
Research Site, Winston-Salem, North Carolina, 27157, United States
모집중

Texas

Research Site, Houston, Texas, 77030, United States
모집중

Washington

Research Site, Seattle, Washington, 98109, United States
모집중
Research Site, Melbourne, 3000, Australia
모집중
Research Site, Nedlands, 6009, Australia
모집중

Alberta

Research Site, Calgary, Alberta, T2N 5G2, Canada
모집중

Ontario

Research Site, Toronto, Ontario, M5G 2M9, Canada
모집중

Quebec

Research Site, Montreal, Quebec, H3T 1R2, Canada
모집중
Research Site, Hangzhou, 310003, China
모집중
Research Site, Shanghai, 200025, China
모집중
Research Site, København Ø, 2100, Denmark
모집중
Research Site, Pessac, 33604, France
모집중
Research Site, Villejuif, 94805, France
모집중
Research Site, München, 81675, Germany
모집중
Research Site, Ulm, 89081, Germany
모집중
Research Site, Würzburg, 97080, Germany
모집중
Research Site, Bologna, 40138, Italy
모집중
Research Site, Milan, 20133, Italy
모집중
Research Site, Chūōku, 104-0045, Japan
모집중
Research Site, Kashiwa, 277-8577, Japan
모집중
Research Site, Barcelona, 08035, Spain
모집중
Research Site, L'Hospitalet de Llobregat, 08908, Spain
모집중
Research Site, Madrid, 28040, Spain
모집중