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GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma

2026년 6월 25일 업데이트: Chunji Gao, Chinese PLA General Hospital

Exploratory Clinical Study of GoFast CAR T-Cell Platform Targeting CD19 CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma

This is an investigator-initiated, prospective, open-label exploratory clinical study designed to evaluate the safety and preliminary efficacy of GoFast CD19 CAR T-cell therapy in adult patients with recurrent or refractory B-cell lymphoma. Eligible patients will undergo screening, baseline assessment, peripheral blood or leukapheresis collection, lymphodepleting chemotherapy, and intravenous infusion of GoFast CD19 CAR T cells. The study plans to enroll 9 participants using a sequential dose-escalation design. The primary outcome is objective response rate, and secondary outcomes include complete remission rate, overall survival, progression-related survival outcomes, duration of response, MRD negativity, and adverse events.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This study will enroll adult patients with recurrent or refractory B-cell lymphoma who are CD19-positive and meet the protocol-defined eligibility criteria. After signing informed consent, participants will undergo screening assessments, including medical history, physical examination, performance status assessment, laboratory tests, infection screening, imaging evaluation, and assessment of feasibility for CAR T-cell preparation.

Eligible participants will undergo peripheral blood or leukapheresis collection for preparation of autologous GoFast CD19 CAR T cells. Before CAR T-cell infusion, participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3. After completion of lymphodepletion, GoFast CD19 CAR T cells will be administered by intravenous infusion according to the assigned dose cohort.

The study uses a dose-escalation design with three planned dose cohorts: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, and 1.2 × 10^6 cells/kg. Each participant will receive a fixed dose according to the assigned cohort. Dose escalation will proceed only after review of safety data from the previous cohort and confirmation that no dose-limiting toxicity or other unacceptable safety signal has occurred.

Participants will be closely monitored after CAR T-cell infusion for adverse events, including cytokine release syndrome, neurotoxicity, tumor lysis syndrome, cytopenia, infection, organ dysfunction, and laboratory abnormalities. CAR T-cell expansion, lymphocyte subsets, cytokines, blood routine tests, biochemical tests, coagulation function, and organ function will be evaluated at protocol-defined time points.

Tumor response will be assessed using imaging and clinical evaluation at predefined follow-up visits, including Day 28 and Week 12 after CAR T-cell infusion. Participants with complete or partial response will continue follow-up for up to 1 year after enrollment. The primary endpoint is objective response rate. Secondary endpoints include complete remission rate, overall survival, time to progression, disease-free survival, duration of response, event-free survival, MRD negativity rate, and the incidence and severity of adverse events.

연구 유형

중재적

등록 (추정된)

9

단계

  • 초기 1단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100071
        • Chinese PLA General Hospital
        • 연락하다:

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Age 18 years or older.
  • Histologically or cytologically confirmed primary refractory or relapsed/progressive large B-cell lymphoma.
  • Expected survival of more than 3 months.
  • CD19-positive B-cell lymphoma confirmed by flow cytometry or immunohistochemistry.
  • ECOG performance status of 0 to 2 or KPS score greater than 80.
  • Adequate venous access for leukapheresis or peripheral blood collection, with no contraindication to blood cell separation.
  • White blood cell count ≥ 1 × 10^9/L and lymphocyte count ≥ 0.3 × 10^9/L.
  • INR < 1.7 or prothrombin time prolonged by less than 4 seconds above the normal value.
  • ALT and AST ≤ 2.5 × upper limit of normal.
  • Total bilirubin ≤ 2.0 mg/dL, equivalent to 34.2 μmol/L.
  • Able to understand and voluntarily sign the written informed consent form.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Active hepatitis B virus or hepatitis C virus infection.
  • HIV/AIDS infection.
  • Any uncontrolled active infection.
  • Systemic corticosteroid use within 2 weeks before signing informed consent, except inhaled corticosteroids.
  • Active cardiac disease requiring treatment or poorly controlled hypertension.
  • Unstable or active ulcer disease or gastrointestinal bleeding.
  • History of organ transplantation or currently awaiting organ transplantation.
  • Central nervous system involvement by lymphoma.
  • Current participation in another clinical trial.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical study.

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: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dose Cohort 1: 0.3 × 10^6 Cells/kg
Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 0.3 × 10^6 cells/kg.
생물학적: GoFast CD19 CAR T Cells
GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, or 1.2 × 10^6 cells/kg.
다른 이름들:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
실험적: Dose Cohort 2: 0.6 × 10^6 Cells/kg
Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 0.6 × 10^6 cells/kg.
생물학적: GoFast CD19 CAR T Cells
GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, or 1.2 × 10^6 cells/kg.
다른 이름들:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
실험적: Dose Cohort 3: 1.2 × 10^6 Cells/kg
Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 1.2 × 10^6 cells/kg.
생물학적: GoFast CD19 CAR T Cells
GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, or 1.2 × 10^6 cells/kg.
다른 이름들:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate
기간: Up to 12 weeks after CAR T-cell infusion
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to the 2014 Lugano lymphoma response criteria after GoFast CD19 CAR T-cell infusion.
Up to 12 weeks after CAR T-cell infusion

2차 결과 측정

결과 측정
측정값 설명
기간
Complete Remission Rate
기간: Up to 12 weeks after CAR T-cell infusion
Complete remission rate is defined as the proportion of participants who achieve complete response according to the 2014 Lugano lymphoma response criteria after GoFast CD19 CAR T-cell infusion.
Up to 12 weeks after CAR T-cell infusion
Overall Survival
기간: Up to 52 weeks after enrollment
Overall survival is defined as the time from GoFast CD19 CAR T-cell infusion to death from any cause.
Up to 52 weeks after enrollment
Time to Progression
기간: Up to 52 weeks after enrollment
Time to progression is defined as the time from GoFast CD19 CAR T-cell infusion to documented disease progression.
Up to 52 weeks after enrollment
Disease-Free Survival
기간: Up to 52 weeks after enrollment
Disease-free survival is defined as the time from achievement of response after GoFast CD19 CAR T-cell infusion to disease recurrence, disease progression, or death.
Up to 52 weeks after enrollment
Duration of Response
기간: Up to 52 weeks after enrollment
Duration of response is defined as the time from first documented complete response or partial response to disease progression, relapse, or death.
Up to 52 weeks after enrollment
Event-Free Survival
기간: Up to 52 weeks after enrollment
Event-free survival is defined as the time from GoFast CD19 CAR T-cell infusion to disease progression, relapse, initiation of new anti-lymphoma therapy, or death from any cause.
Up to 52 weeks after enrollment
MRD Negativity Rate
기간: Up to 12 weeks after CAR T-cell infusion
MRD negativity rate is defined as the proportion of participants who achieve minimal residual disease negativity after GoFast CD19 CAR T-cell therapy, as assessed by protocol-defined laboratory methods.
Up to 12 weeks after CAR T-cell infusion
Incidence and Severity of Adverse Events Assessed by CTCAE v4.03
기간: From informed consent to 52 weeks after enrollment
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From informed consent to 52 weeks after enrollment
Incidence and Severity of Cytokine Release Syndrome Assessed by ASTCT Consensus Criteria
기간: Up to 28 days after CAR T-cell infusion
Cytokine release syndrome will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Up to 28 days after CAR T-cell infusion
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome Assessed by ASTCT Criteria
기간: Up to 28 days after CAR T-cell infusion
Immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to ASTCT consensus criteria.
Up to 28 days after CAR T-cell infusion

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Chinese PLA General Hospital

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)

2026년 6월 30일

기본 완료 (추정된)

2027년 9월 30일

연구 완료 (추정된)

2028년 6월 30일

연구 등록 날짜

최초 제출

2026년 6월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 25일

처음 게시됨 (실제)

2026년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 25일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GoFast CD19CAR-T

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared to protect participant privacy and confidentiality, particularly because this is a small exploratory CAR T-cell therapy study.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

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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