A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis (RECLAIM-LN)
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)
연구 개요
상태
개입 / 치료
상세 설명
This is a multicenter, phase 2 single-arm trial designed to evaluate the efficacy and safety of FT819 in participants with moderate-to-severe systemic lupus erythematosus (SLE) with Class III/IV lupus nephritis (LN) (with or without concomitant Class V involvement) refractory to at least 2 immunosuppressive therapies prior to trial intervention.
Participants will undergo a screening period of up to 28 days. Following screening, trial intervention will consist of bendamustine administration followed by a single dose of FT819. Efficacy, safety, and exploratory assessments will be conducted at predefined timepoints through Month 24 of post-treatment follow-up (PTFU). Following completion of these scheduled assessments, participants will continue in long-term follow-up (LTFU) for up to 15 years after FT819 administration to monitor ongoing safety and survival.
Efficacy and disease activity will be assessed using standard LN measures, including complete renal response (CRR) and PRR (partial renal response), as well as clinician-reported outcomes, such as the SLEDAI-2K, BILAG, and PGA, performed at specified timepoints.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Fate Clinical Trials
- 전화번호: 858-875-1800
- 이메일: clinicaltrials@fatetherapeutics.com
연구 연락처 백업
- 이름: Natalie Shiff, MD
연구 장소
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California
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Beverly Hills, California, 미국, 90210
- 모병
- Wallace Rheumatic Studies Center
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Fontana, California, 미국, 92335
- 모병
- Kaiser Permanente Fontana
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Fullerton, California, 미국, 92835
- 모병
- Providence Medical Foundation
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Irvine, California, 미국, 92868
- 모병
- University of California Irvine
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San Francisco, California, 미국, 64110
- 모병
- University of California San Francisco
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Florida
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Cooper City, Florida, 미국, 33024
- 모병
- Gnp Research
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Gainesville, Florida, 미국, 32610
- 모병
- University of Florida Clinical Research Center
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Miami, Florida, 미국, 33155
- 모병
- Nicklaus Children's Hospital
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Miami, Florida, 미국, 33133
- 모병
- Miami Dermatology and Laser Research
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Nebraska
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Omaha, Nebraska, 미국, 68105
- 모병
- University of Nebraska Medical Center
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North Carolina
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Fayetteville, North Carolina, 미국, 28304
- 모병
- Cross Creek Medical Clinic
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Texas
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Dallas, Texas, 미국, 75390
- 모병
- The University of Texas Southwestern Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
INCLUSION CRITERIA:
- Age ≥12 to ≤70 years
- Diagnosis of SLE per EULAR/ACR 2019 classification criteria
- Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification
Positivity for at least one of the following autoantibodies at screening:
- Antinuclear antibody (ANA)
- Anti-double-stranded DNA (anti-dsDNA) or
- Anti-Smith antibody
Active disease, defined as:
a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g/g; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible
- Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN
EXCLUSION CRITERIA:
- Evidence of inadequate organ function during the screening period
- Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
- History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity
- Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
- Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant
- History of malignancy in the prior 5 years
- Known allergy to the following FT819 components: albumin (human) or DMSO
- History of intolerance or contraindication to bendamustine
- Body weight <30 kg
- Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: FT819
FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CD19-targeted CAR regulated by the TRAC locus, given as a single IV infusion
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Single Intravenous (IV) infusion of FT819 administered on Day 1
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Complete Renal Response (CRR) at Week 26
기간: Week 26
|
Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria:
|
Week 26
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
CRR at Week 52
기간: Week 52
|
Proportion of participants who achieve CRR at Week 52
|
Week 52
|
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CRR at Week 104
기간: Week 104
|
Proportion of participants who achieve CRR at Week 104
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Week 104
|
|
Overall Renal Response
기간: Up to approximately 2 years
|
Proportion of participants who achieve an overall renal response, defined as achievement of either CRR or partial renal response (PRR), evaluated at Week 26, Week 52, and Week 104
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Up to approximately 2 years
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Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104
기간: Up to approximately 2 years
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PRR is defined as achievement of all of the following:
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Up to approximately 2 years
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Lupus Low Disease Activity State (LLDAS)
기간: Up to approximately 2 years
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Proportion of participants who achieve lupus low disease activity state (LLDAS) at Week 26, Week 52, and Week 104
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Up to approximately 2 years
|
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Definition of Remission in SLE (DORIS)
기간: Up to approximately 2 years
|
Proportion of participants who achieve a definition of remission in SLE (DORIS) at Week 26, Week 52, and Week 104
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Up to approximately 2 years
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Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
기간: Up to approximately 2 years
|
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (adults age ≥18 years) score at Week 26, Week 52, and Week 104
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Up to approximately 2 years
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Proportion of participants who achieve SLE Responder Index-4 (SRI-4)
기간: Up to approximately 2 years
|
Proportion of participants who achieve SLE Responder Index-4 (SRI-4) at Week 26, Week 52, and Week 104
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Up to approximately 2 years
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FT819-201
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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