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

2026年6月25日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

9

段階

  • 初期フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100071
        • Chinese PLA General Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
生物学的：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.
他の名前：
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
実験的：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.
生物学的：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.
他の名前：
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
実験的：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.
生物学的：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.
他の名前：
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Complete Remission Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Chinese PLA General Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月30日

一次修了 (推定)

2027年9月30日

研究の完了 (推定)

2028年6月30日

試験登録日

最初に提出

2026年6月22日

QC基準を満たした最初の提出物

2026年6月25日

最初の投稿 (実際)

2026年6月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月25日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • GoFast CD19CAR-T

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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