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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed or Refractory Large B-cell Lymphoma
• Intervention / Treatment: Biological: GoFast CD19 CAR T Cells

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chunji Gao, PhD; Phone Number: +86-13911536256; Email: gaochunji301@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100071
      • Chinese PLA General Hospital
      • Contact: Chunji Gao, PhD; Phone Number: +86-13911536256; Email: gaochunji301@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.; Other Names: CD19 CAR T-Cell Therapy; Autologous CD19 CAR T Cells; GoFast CD19CAR-T; CD19-Targeted CAR T Cells
Experimental: 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.	Biological: 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.; Other Names: CD19 CAR T-Cell Therapy; Autologous CD19 CAR T Cells; GoFast CD19CAR-T; CD19-Targeted CAR T Cells
Experimental: 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.	Biological: 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.; Other Names: CD19 CAR T-Cell Therapy; Autologous CD19 CAR T Cells; GoFast CD19CAR-T; CD19-Targeted CAR T Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Remission Rate	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	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	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	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	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	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	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	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	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	Immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to ASTCT consensus criteria.	Up to 28 days after CAR T-cell infusion

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CD19; Dose Escalation; Large B-Cell Lymphoma; CAR T-Cell Therapy; Relapsed or Refractory Lymphoma; GoFast Platform; Autologous CAR T Cells
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Lymphoma
• Other Study ID Numbers: GoFast CD19CAR-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No