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

NCT07670260 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GoFast CD19CAR-T
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed or Refractory Large B-cell Lymphoma

Keywords

CD19; CAR T-Cell Therapy; GoFast Platform; Large B-Cell Lymphoma; Relapsed or Refractory Lymphoma; Dose Escalation; Autologous CAR T Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Complete Remission Rate

  Up to 12 weeks after CAR T-cell infusion

• Overall Survival

  Up to 52 weeks after enrollment

• Time to Progression

  Up to 52 weeks after enrollment

• Disease-Free Survival

  Up to 52 weeks after enrollment

• Duration of Response

  Up to 52 weeks after enrollment

Study Arms (3)

Dose Cohort 1: 0.3 × 10^6 Cells/kg

EXPERIMENTAL

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

Dose Cohort 2: 0.6 × 10^6 Cells/kg

EXPERIMENTAL

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

Dose Cohort 3: 1.2 × 10^6 Cells/kg

EXPERIMENTAL

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

Interventions

GoFast CD19 CAR T Cells BIOLOGICAL

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.

Also known as: CD19 CAR T-Cell Therapy, Autologous CD19 CAR T Cells, GoFast CD19CAR-T, CD19-Targeted CAR T Cells

Dose Cohort 1: 0.3 × 10^6 Cells/kg; Dose Cohort 2: 0.6 × 10^6 Cells/kg; Dose Cohort 3: 1.2 × 10^6 Cells/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chunji Gao, PhD

CONTACT

+86-13911536256; gaochunji301@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is an open-label, sequential dose-escalation study with three planned dose cohorts of GoFast CD19 CAR T cells: 0.3 × 10\^6 cells/kg, 0.6 × 10\^6 cells/kg, and 1.2 × 10\^6 cells/kg. Participants will be assigned sequentially to dose cohorts. Dose escalation will proceed only after safety review of the previous cohort.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)