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임상시험 NCT06750133 (CNK-UT)은(는) 급성 이식편대숙주병에 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
Universal CNK-UT Therapy for Refractory aGVHD 1상 23 다기관 오픈 라벨 연구자 주도
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 NCT06750133 (CNK-UT)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 급성 이식편대숙주병에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 12월 14일에 시작되어 23명의 참여자를 모집하고 있습니다. First Affiliated Hospital of Zhejiang University이(가) 진행하며, 2026년 6월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 12월 27일에 갱신되었습니다.
간단한 개요
This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent aGVHD.
상세한 설명
This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent acute graft-versus-host disease (aGvHD) after allogeneic hematopoietic stem cell...더 보기
공식 제목
A Study of Universal CNK-UT Cell Injection in Patients With Refractory Acute Graft-versus-host Disease
질환명
급성 이식편대숙주병기타 연구 식별자
- CNK-UT
- CNK-UT-IIT202305
NCT 번호
실제 연구 시작일
2024-12-14
최신 업데이트 게시
2024-12-27
예상 연구 완료일
2026-06-30
계획된 등록 인원
23
연구종류
중재연구
단계/상
1상
상태
모집중
키워드
CNK-UT cell
aGVHD
allo-HSCT
steroids refractory
cellular therapy
aGVHD
allo-HSCT
steroids refractory
cellular therapy
주요 목적
치료
설계 할당
해당 없음
중재 모델
순차설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적CNK-UT cell Therapy 1. Dose Escalation：Single-dose intravenous injection of CNK-UT cells (3×10\^7 CNK+ cells/kg).
2. Dose Expansion：Multiple-dose intravenous injection of CNK-UT cells (6-10×10\^7 CNK+ cells/kg)according to the results of dose escalation. | Chimeric Natural Killer Receptor Universal T-cells (CNK-UT) Dose Escalation (Single Ascending Dose Study, SAD): During SAD study stage, the participants will be intravenous infused with CNK-UT cells (3×10\^7 CNK+ cells/kg)with a"3 +3" design to determine the maximum tolerated dose. During single ascending dose (SAD) study stage, the participants will receive a single dose of CNK-UT cells before the DLT observation period (21 days). If the participants do not experience DLT, t...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Incidence of Treatment Related adverse events (AEs) | Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs) assessed by NCI-CTCAE v5.0 criteria | up to 1 year |
Identification of Maximum Tolerated Dose (MTD) & incidence of Dose-limiting Toxicities (DLTs) | Incidence of dose-limiting toxicities (DLTs) | up to 21 days since first infusion of CNK-UT cells |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Objective Response Rate (ORR) | Overall response is defined as either a complete or partial response (CR+PR), the response should be confirmed no less than 4 weeks after the first evaluation. | Overall response is defined as either a complete or partial response (CR+PR), the response should be confirmed no less than 4 weeks after the first evaluation. |
Best Overall Response (BOR) | The best efficacy recorded from the beginning of treatment to the progression or recurrence of the disease. | 6 months |
Duration of Response (DOR) | The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause. | 6 months |
Progression-free Survival (PFS) | The period from the day when the participant receives the cell therapy to the first recorded disease progression (whether treated or not) or death of any cause, which occurs first. | 6 months |
Overall survival (OS) | The period from the first infusion to any cause of death. | 6 months |
Pharmacokinetics (PK) (Cmax) | The Peak Plasma concentration (Cmax) of amplified CNK-UT DNA in peripheral blood after infusion. | up to 48 weeks |
Pharmacokinetics (PK) (Tmax) | The time to reach the maximum concentration (Tmax) | up to 48 weeks |
Pharmacokinetics (PK) | The Area under the plasma concentration versus time curve (AUC) of amplified CNK-UT DNA in peripheral blood after infusion. | up to 48 weeks |
Levels of peripheral blood lymphocyte subsets | Percentage of CD45+CD3+TCR+T cell、CD3+CD8+ CD25+ CD69+T cell、CD3+CD4+CD25+ CD69+ T cell and Treg（CD4+CD25+FoxP3+）cell in peripheral blood detected by FCM after infusion. | up to 48 weeks |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
14 Years
참여 가능한 성별
전체
- Aged 14-70 years, male or female;
- Participants diagnosed with grade II~IV steroid-refractory/resistant or steroid-dependent aGVHD after allogeneic hematopoietic stem cell transplantation.
- ECOG physical status score 0~3;
- Estimated life expectancy > 12 weeks;
- Female participants of childbearing age must undergo a serum or urine pregnancy test before enrollment, and the results must be negative, and agree to take acceptable measures to minimize the possibility of pregnancy during the trial; For female participants of childbearing age or male participants whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the study and for at least 6 months following the last dose of the study cells infusion.
- Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.
- Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and / or radical resection of carcinoma in situ.
- Participants with a history of organ transplantation;
- Participants who have previously undergone more than one allogeneic hematopoietic stem cell transplantation.
- Uncontrolled hypertension as determined by principal investigator, a history of hypertensive crisis or hypertensive encephalopathy; symptomatic congestive heart failure (New York Heart Association classification III-IV); symptomatic or poorly controlled arrhythmias; a history of congenital long QT syndrome or a corrected QT interval (QTc) > 500 ms at screening (calculated using the Fridericia method)..
- Systemic diseases deemed unstable by principal investigator include, but are not limited to, severe pulmonary, hepatic, renal, or metabolic disorders that require pharmacological intervention (excluding complications related to allogeneic hematopoietic stem cell transplantation).
- Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis infection.
- Severe infections that are active or poorly controlled clinically.
- Participants who have received treatment from other clinical trials within 12 weeks prior to the initiation of the study.
- Participants who have previously used any gene therapy products prior to the initiation of the study.
- Allergic to components of CNK-UT injection.
- Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.
- Women who are pregnant or breastfeeding, as well as male or female participants who have planned for birth within 1 year after receiving medication.
- Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and/or uncertainty in survival assessments.
- Other situations that the participant is identified by the investigator as unsuitable to participate in the study.
First Affiliated Hospital of Zhejiang UniversityST Phi Therapeutics Co., Ltd연구 책임자
Yi Luo, 책임연구자, Professor, First Affiliated Hospital of Zhejiang University
연구 대표 연락처
연락처: Li Luo, MD, +860571-87233801, [email protected]
연락처: Yibo Wu, MD, +860571-87233801, [email protected]
2 1개국에 임상시험 장소
Fujian
First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Ting Yang, MD, 연락처, 86-591-88711593, [email protected]
모집중
Zhejiang
The first affiliated hospital of zhejiang university, school of medicine., Hangzhou, Zhejiang, 310000, China
Duo Lv, MD, 연락처, +860571-87236560, [email protected]
모집중