Relapsed or Refractory Large B-cell LymphomaEarly Phase 1NCT07670260
GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma
A Early Phase 1 study testing GoFast CD19 CAR T Cells in people with Relapsed or Refractory Large B-cell Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Large B-cell Lymphoma
- What is being tested?
- GoFast CD19 CAR T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071
Chunji Gao, PhD, +86-13911536256, gaochunji301@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- GoFast CD19 CAR T Cells
- Keywords
- CD19, CAR T-Cell Therapy, GoFast Platform, Large B-Cell Lymphoma, Relapsed or Refractory Lymphoma, Dose Escalation, Autologous CAR T Cells
- Medical subject headings
- Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoFast CD19 CAR T CellsBiological
Also called CD19 CAR T-Cell Therapy, Autologous CD19 CAR T Cells, GoFast CD19CAR-T, CD19-Targeted 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: GoFast CD19 CAR T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks after CAR T-cell infusion
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 28 days after CAR T-cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunji Gao, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670260
- Sponsor's protocol ID
- GoFast CD19CAR-T
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of GoFast CAR T-Cell Platform Targeting CD19 CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07670260
- Acronym / sponsor ID
- GoFast CD19CAR-T
- Keywords
- CD19, CAR T-Cell Therapy, GoFast Platform, Large B-Cell Lymphoma, Relapsed or Refractory Lymphoma, Dose Escalation, Autologous CAR T Cells
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose Cohort 1: 0.3 × 10^6 Cells/kg | Experimental | Biological: GoFast CD19 CAR T CellsParticipants 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. |
| Dose Cohort 2: 0.6 × 10^6 Cells/kg | Experimental | Biological: GoFast CD19 CAR T CellsParticipants 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. |
| Dose Cohort 3: 1.2 × 10^6 Cells/kg | Experimental | Biological: GoFast CD19 CAR T CellsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoFast CD19 CAR T CellsAlso: CD19 CAR T-Cell Therapy, Autologous CD19 CAR T Cells, GoFast CD19CAR-T, CD19-Targeted CAR T CellsGoFast 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. | Biological | 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 |
Primary outcome
Objective Response Rate
Time frame: 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.
10 secondary outcomes
Complete Remission Rate
Time frame: Up to 12 weeks after CAR T-cell infusion
Overall Survival
Time frame: Up to 52 weeks after enrollment
Time to Progression
Time frame: Up to 52 weeks after enrollment
Disease-Free Survival
Time frame: Up to 52 weeks after enrollment
Duration of Response
Time frame: Up to 52 weeks after enrollment
Event-Free Survival
Time frame: Up to 52 weeks after enrollment
MRD Negativity Rate
Time frame: Up to 12 weeks after CAR T-cell infusion
Incidence and Severity of Adverse Events Assessed by CTCAE v4.03
Time frame: From informed consent to 52 weeks after enrollment
Incidence and Severity of Cytokine Release Syndrome Assessed by ASTCT Consensus Criteria
Time frame: Up to 28 days after CAR T-cell infusion
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome Assessed by ASTCT Criteria
Time frame: Up to 28 days after CAR T-cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GoFast CD19 CAR T Cells in people with Relapsed or Refractory Large B-cell Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunji Gao, PhD (+86-13911536256, gaochunji301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 12 weeks after CAR T-cell infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.