CD70 발현 암 환자를 대상으로 한 CD70 결합 키메라 항원 수용체 형질도입 말초혈액 림프구 투여 임상시험¶

Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목	내용
등록번호	NCT02830724
상태	모집 중
단계	1상/2상
시험 약물/중재	Cyclophosphamide, Fludarabine, Aldesleukin, Anti-hCD70 CAR transduced PBL
대상 질환	Pancreatic Cancer, Renal Cell Cancer, Breast Cancer, Melanoma, Ovarian Cancer
스폰서	National Cancer Institute (NCI)
연령·성별	18 Years ~ 72 Years · ALL
목표 인원	124
시작 / 1차 완료 예정	2017-04-06 / 2029-01-01
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (United States)
결과 게시	아니오
최근 갱신	2026-08-13

문의처 (등록된 중앙 연락처)¶

NCI SB Immunotherapy Recruitment Center (866) 820-4505 IRC@nih.gov

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요¶

이 연구는 췌장암을 포함하여 CD70을 발현하는 고형암 환자를 대상으로 환자의 백혈구에 유전자 조작을 가한 항-CD70 CAR 세포(anti-hCD70 CAR transduced PBL)를 주입하는 1상 및 2상 임상시험입니다. 1상에서는 림프구 고갈 화학요법 및 고용량 aldesleukin(알데스류킨, IL-2)과 함께 세포 치료제를 투여했을 때의 안전성을 평가합니다. 2상에서는 CD70 발현 종양의 퇴축을 유도할 수 있는지 평가합니다. 전체 목표 환자 수는 최대 124명입니다.

임상시험의 목표 인원은 최대 124명이며 1상에 약 38명, 2상 코호트별로 각 43명이 참여합니다.
중재 방법으로 cyclophosphamide(시클로포스파미드), fludarabine(플루다라빈), aldesleukin 및 항-CD70 CAR 형질도입 말초혈액 림프구를 사용합니다.
참여 대상은 표준 치료 후 진행되었거나 재발한 전이성 또는 절제 불가능한 CD70 발현 암 환자입니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: - 18세 이상 72세 이하의 연령 - 표준 치료 이후 진행되었거나 재발한 전이성 또는 절제 불가능한 CD70 발현 암 환자 - 조직검사를 통해 확인된 CD70 발현 (1상: 평가 가능한 종양, 2상: RECIST v1.1 기준 측정 가능한 종양) - ECOG 전신 수행 능력 상태 0 또는 1 - HIV, B형 간염, C형 간염 음성 - 적절한 조혈모세포 및 장기 기능 (ANC 1000/mm3 초과, 혈소판 80,000/mm3 이상 등) 제외 기준: - 임신 또는 수유 중인 여성 - 동시 전신 스테로이드 치료 진행 중인 환자 - 치료가 필요한 활동성 전신 감염, 응고 장애, 활동성 주요 의학적 질환 - 면역결핍 질환 또는 면역억제 조치가 필요한 자가면역 질환 병력 - cyclophosphamide, fludarabine, aldesleukin에 대한 중증 과민반응 병력 - 관상동맥 재개통술 또는 허혈성 증상 병력 - 다른 임상시험용 약물을 투여받고 있는 환자

선정/제외 기준 원문 (영어)

INCLUSION CRITERIA:
For Phase I: Evaluable, unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).
For Phase II: Measurable (per RECIST v1.1 criteria), unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).
Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.
Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred.
Patients with 3 or fewer brain metastases that are less than or equal to 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
Age greater than or equal to 18 years and less than or equal to 72 years.
Clinical performance status of ECOG 0 or 1
Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for women and for four months after treatment for men.
Women of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.

NOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and/ or ultrasound may be performed for clarification.

-Serology

--Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental

treatment and more susceptible to its toxicities.)

Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.

-Hematology * ANC greater than 1000/mm(3) without the support of filgrastim * WBC greater than or equal to 2500/mm(3) * Platelet count greater than or equal to 80,000/mm(3) * Hemoglobin > 8.0 g/dL. Subjects may be transfused to reach this cut-off.

-Chemistry * Serum ALT/AST less than or equal to 5.0 times ULN * Serum creatinine less than or equal to 1.6 mg/dL * Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL.

Patients must have completed any prior systemic therapy at the time of enrollment.

Note: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less.

Ability of subject to understand and the willingness to sign a written informed consent document.
Willing to sign a durable power of attorney.
Subjects must be co-enrolled on the NCI-SB cell harvest protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).

EXCLUSION CRITERIA:

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
Concurrent systemic steroid therapy.
Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
History of hematopoietic autoimmune disease or any autoimmune disease requiring immunosuppressive measures.
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
History of coronary revascularization or ischemic symptoms.
For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.
For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.
Patients who are receiving any other investigational agents.

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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