Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies
Previous experience with antibody therapy in both NHL and CLL warrants further exploration of new antibody treatments for these diseases.
Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1 is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated in clinical trials of patients with B-cell malignancies and autoimmune disorders.
This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one prior standard treatment. All patients will receive hLL1 administered intravenously once daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) Patients will be assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per statistical plan) in order to determine the maximum tolerated dose (MTD) for this administration schedule.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10021
- Weill Cornell Medical College
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed diagnosis of recurrent B cell non-Hodgkin's lymphoma or diagnosis of recurrent chronic lymphocytic leukemia
- Patient has received at least one prior treatment with standard chemotherapy and at least one prior treatment with rituximab (negative HAHA test required if received prior humanized antibody treatment)
- Patient has not received anti-cancer therapy within 28 days of treatment unless disease progression has been demonstrated and toxicities from prior therapy have resolved
- Available tumor tissue (lymph node/mass, blood or bone marrow) for correlative analyses (paraffin or frozen, recent or archived)
- Measurable disease as defined by a tumor mass > 1.5 cm in one dimension or WBC > 5,000 (CLL patients)
- Age > 18 years
- Patient has KPS > 50%
- Absolute granulocyte count > 1000 cells/mm3
- Platelet count > 50,000 cells/mm3
- Creatinine < 2.0 x ULN
- Total bilirubin < 2.0 x ULN
- Patient agrees to use birth control if of reproductive potential
- Patient has signed IRB-approved informed consent
Exclusion Criteria:
- Known central nervous system (CNS) involvement by lymphoma
- Known HIV disease
- Patient is pregnant or nursing
- Patient is receiving other investigational drugs
- Known serum human anti-human antibodies (HAHA)
- Estimated life expectancy of < 3 months
공부 계획
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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: Study Treatment
This study is a single arm study
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hLL1 administered intravenously once daily Monday through Friday for 2 consecutive weeks (10 total doses) at one of 4 planned dose levels: 1.5, 4, 6 or 8 mg/kg.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To determine the toxicity profile and maximum tolerated dose (MTD) of hLL1 when administered to patients with recurrent non-Hodgkin's lymphoma and chronic lymphocytic leukemia
기간: duration of study
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duration of study
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- 0608008669
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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