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Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30) (ANCILE-30)

2026년 7월 22일 업데이트: The Methodist Hospital Research Institute

This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30 (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas.

Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of the investigational product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by infusion of autologous C7R.CD30-CAR-EBVSTs.

The primary objective is to evaluate safety. Secondary and exploratory objectives include evaluation of antitumor effect, expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This is a Phase I study to evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes (EBVSTs) genetically modified to express a constitutively active interleukin-7 receptor (C7R) and a CD30-specific chimeric antigen receptor (CAR) (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas. The study will also evaluate the antitumor effect of C7R.CD30-CAR-EBVSTs, the expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.

Autologous CD30 CAR T cells have demonstrated clinical activity in patients with relapsed or refractory CD30-positive lymphomas but have shown limited persistence. Epstein-Barr virus-specific T lymphocytes (EBVSTs) have demonstrated long-term persistence following adoptive transfer. In this study, EBVSTs are used as the cellular platform to express both a CD30 CAR and a constitutively active IL7 receptor (C7R). The investigational cell product also provides a mechanism for rapid elimination of transduced cells if clinically indicated.

Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of an autologous C7R.CD30-CAR-EBVST product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by intravenous infusion of C7R.CD30-CAR-EBVSTs. Participants who meet retreatment criteria, as defined in the protocol, may receive additional treatment cycles. Following treatment, participants will undergo scheduled follow-up evaluations including physical examinations, laboratory testing, and imaging studies to assess safety and disease status.

Blood samples are collected at multiple time points after infusion to evaluate persistence of the infused cells. Tumor assessments are performed using imaging and, when clinically indicated, biopsy.

Participants are followed longitudinally for up to 15 years after the most recent infusion.

연구 유형

중재적

등록 (추정된)

21

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Premal Lulla, MD
  • 전화번호: 713-441-1450
  • 이메일: lulla@bcm.edu

연구 장소

  • 미국
    • Texas
      • Houston, Texas, 미국, 77030
        • Houston Methodist Hospital
        • 연락하다:
          • Premal Lulla, MD
          • 전화번호: 713-441-1450
          • 이메일: lulla@bcm.edu

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Procurement Inclusion Criteria:

Participants must meet the protocol-defined procurement eligibility criteria before collection of peripheral blood mononuclear cells for manufacture of the investigational product, including:

  1. Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.
  2. CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory.
  3. Age 16 to 75 years.
  4. Hemoglobin ≥7.0(may be transfused value).
  5. Karnofsky or Lansky score of > 60%
  6. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent.

Procurement Exclusion Criteria:

  1. Active HIV or HTLV infection (testing may be pending at procurement).

  2. Active bacterial, fungal, or viral infection.

    ____________________________________________________________________________

Treatment Inclusion Criteria:

Participants with a successfully manufactured product must continue to satisfy the protocol-defined treatment eligibility criteria before receiving study treatment, including:

  1. Diagnosis and clinical course falling into one of the following categories:

    • Hodgkin lymphoma
    • CD30+ aggressive B-cell lymphoma
    • ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma
    • ALK-positive anaplastic T cell lymphoma
  2. CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy
  3. Age 16 to 75 years.
  4. Bilirubin ≤ 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin ≤ 3 times the upper limit of normal).
  5. AST ˂ 3 times the upper limit of normal
  6. Estimated GFR > 50 mL/min
  7. Pulse oximetry of > 90% on room air
  8. Karnofsky or Lansky score of > 60%
  9. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after study is concluded. Male partner should use a condom
  10. Informed consent explained to, understood by and signed by patient/guardian. Patient/Guardian given copy of informed consent.

Treatment Exclusion Criteria:

  1. Received an investigational cell therapy or vaccine within the past 6 weeks.
  2. Received an investigational small molecule within the past 2 weeks.
  3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.
  4. History of hypersensitivity reactions to murine protein-containing products
  5. Pregnancy or breastfeeding.
  6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion)
  7. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
  8. Active significant, uncontrolled bacterial, viral or fungal infection.
  9. Symptomatic cardiac disease (NYHA Class III or IV disease).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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
실험적: Autologous C7R.CD30-CAR-EBVSTs
Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of autologous C7R.CD30-CAR-EBVSTs. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by intravenous infusion of autologous C7R.CD30-CAR-EBVSTs. Participants who meet protocol-defined retreatment criteria may receive additional treatment cycles.
생물학적: Autologous C7R.CD30-CAR-EBVSTs
Autologous Epstein-Barr virus-specific T lymphocytes genetically modified to express a constitutively active interleukin-7 receptor (C7R), a CD30-specific chimeric antigen receptor (CAR), and an inducible caspase 9 (iC9) safety switch. The investigational product is manufactured from autologous peripheral blood mononuclear cells and administered by intravenous infusion following lymphodepleting chemotherapy.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Dose-Limiting Toxicities (DLTs)
기간: From initiation of lymphodepleting chemotherapy through 28 days following the initial investigational T-cell infusion.
Dose-limiting toxicity (DLT) is defined as any of the following considered possibly, probably, or definitely related to study cellular products: (1) Grade 5 event without disease progression; (2) CRS: Grade 4, or Grade 3 not improving to ≤Grade 2 within 72 hours despite therapy; (3) ICANS: Grade 4, or Grade 3 not improving within 72 hours despite therapy; (4) Grade ≥3 IEC-HS; (5) Grade 4 neutropenia or thrombocytopenia not attributable to underlying disease or lymphodepleting chemotherapy and not improving to ≤Grade 2 within 42 days, or Grade 3 thrombocytopenia with clinically significant major bleeding; (6) Grade ≥3 vital organ toxicity (except transient hepatic or renal abnormalities improving to ≤Grade 2 within 7 days); (7) other Grade 3 toxicities not attributable to underlying disease or lymphodepleting chemotherapy and not resolving to ≤Grade 2 within 72 hours; (8) Grade ≥2 allergic reaction to T-cell infusion.
From initiation of lymphodepleting chemotherapy through 28 days following the initial investigational T-cell infusion.

2차 결과 측정

결과 측정
측정값 설명
기간
Antitumor Effect
기간: 4 to 6 weeks after the initial C7R.CD30-CAR-EBVST infusion.
Antitumor effect will be assessed by investigator evaluation of objective response (complete response and partial response) using Lugano criteria.[
4 to 6 weeks after the initial C7R.CD30-CAR-EBVST infusion.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The Methodist Hospital Research Institute

협력자

Baylor College of Medicine

수사관

  • 수석 연구원: Helen Heslop, MD, The Methodist Hospital Research Institute
  • 수석 연구원: Premal Lulla, MD, The Methodist Hospital Research Institute

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 15일

기본 완료 (추정된)

2030년 3월 31일

연구 완료 (추정된)

2044년 2월 28일

연구 등록 날짜

최초 제출

2026년 7월 22일

QC 기준을 충족하는 최초 제출

2026년 7월 22일

처음 게시됨 (실제)

2026년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 22일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ANCILE-30

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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