Relapsed/Refractory B-cell LymphomaPhase 1/2CAR/TRuC-TNCT07508605
Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
A Phase 1/2 study testing CAR/TRuC-T in people with Relapsed/Refractory B-cell Lymphoma, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
1. Study Title: A Study on the Efficacy and safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: Primary Objective: To evaluate the safety of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory B-cell Lymphoma
- What is being tested?
- CAR/TRuC-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2027
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled:
- Aged 18 to 75 years, regardless of sex;
- Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;
- ECOG performance status of 0-2;
- Expected survival of at least 3 months;
- CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
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- Patients who are resistant/refractory to CD19 CAR-T cell therapy or have low CD19 expression;
- No severe cardiac, pulmonary, hepatic, or renal disease;
- Able to understand and willing to sign the informed consent form for this study;
- No contraindications to peripheral blood mononuclear cell collection/apheresis;
- At least one measurable and evaluable lesion according to RECIST 1.1;
- Must have previously received standard first-line and second-line therapy;
- No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria
- Subjects meeting any of the following criteria will be excluded:
- History of allergy to any component of the cell product;
- Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹/L, ANC ≤0.5 × 10⁹/L, ALC ≤0.5 × 10⁹/L, or PLT ≤25 × 10⁹/L;
- Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg/dL; ALT or AST >2.5 times the upper limit of normal; serum creatinine ≥2.0 mg/dL;
- New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiography;
- Abnormal pulmonary function, with oxygen saturation <92% on room air;
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
- Grade 3 hypertension with poor blood pressure control despite medication;
- History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
- Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
- Presence of uncontrolled active infection;
- Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
- Receipt of a live vaccine within 4 weeks prior to enrollment;
- Positive for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status;
- History of alcohol abuse, drug abuse, or psychiatric illness;
- Participation in any other clinical study within 3 months prior to enrollment in this study;
- Female subjects meeting any of the following conditions:
- currently pregnant or breastfeeding;
- planning to become pregnant during the study period; or
- of childbearing potential and unwilling or unable to use effective contraception;
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
Who cannot join
None listed.
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, 1 recruiting
- Recruiting
Shenzhen University General Hospital
Shenzhen, Guangdong, 518055
LI YU, PHD, 0755-21839999, wanglixin1991@sohu.com
LI YU, PHD
About this study
- Study Title: A Study on the Efficacy and safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
- Study Objectives: Primary Objective: To evaluate the safety of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Secondary Objective: To evaluate the efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Exploratory Objective: To assess in vivo expansion and persistence of infused CD19/CD20 CAR/TRuC-T cells.
- Participant Intervention:
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Read the detailed description
Detailed Description:
This is a prospective, interventional Phase I/II clinical study designed to evaluate the safety and efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. A total of 20 patients aged 18-75 years with relapsed/refractory B-cell lymphoma will be enrolled. All patients must have histopathologically confirmed disease and positive CD20 expression in tumor tissue.
CD19/CD20 CAR/TRuC-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10^6 CAR-T cells/kg. Eligible subjects (N=20) will be assigned by the investigator to receive CD19/CD20 CAR/TRuC-T cell infusion.
Endpoints:
- Primary Endpoint:
- Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after CD19/CD20 CAR/TRuC-T cell infusion.
- Secondary Endpoints:
- Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;
- Overall survival (OS) and progression-free survival (PFS) at 6 months;
- In vivo expansion and persistence kinetics of infused CD19/CD20 CAR/TRuC-T cells.
- Conditions
- Relapsed/Refractory B-cell Lymphoma
- Being tested
- CAR/TRuC-T
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR/TRuC-TCombination product
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CAR/TRuC-T | Experimental | Not described Receives: Combination Product: CAR/TRuC-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
Adverse events during treatment
Measured: From date of initial treatment to the 30 days after treatment
Secondary outcomes (1)
Disease-related clinical responses
Disease-related clinical responses include CR/PR/SD/PD
Measured: From date of enrollment until the date of clinical responses,up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jan 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory 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
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508605
- Sponsor's protocol ID
- 113
- Other IDs
- 113
- Acronym
- CAR/TRuC-T
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07508605
- Acronym / sponsor ID
- CAR/TRuC-T / 113
- Conditions
- Relapsed/Refractory B-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Apr 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.
- Study Title: A Study on the Efficacy and safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma
- Study Objectives: Primary Objective: To evaluate the safety of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Secondary Objective: To evaluate the efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. Exploratory Objective: To assess in vivo expansion and persistence of infused CD19/CD20 CAR/TRuC-T cells.
- Participant Intervention:
Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Detailed description
Detailed Description:
This is a prospective, interventional Phase I/II clinical study designed to evaluate the safety and efficacy of CD19/CD20 CAR/TRuC-T cell therapy in patients with relapsed/refractory B-cell lymphoma. A total of 20 patients aged 18-75 years with relapsed/refractory B-cell lymphoma will be enrolled. All patients must have histopathologically confirmed disease and positive CD20 expression in tumor tissue.
CD19/CD20 CAR/TRuC-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10^6 CAR-T cells/kg. Eligible subjects (N=20) will be assigned by the investigator to receive CD19/CD20 CAR/TRuC-T cell infusion.
Endpoints:
- Primary Endpoint:
- Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after CD19/CD20 CAR/TRuC-T cell infusion.
- Secondary Endpoints:
- Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;
- Overall survival (OS) and progression-free survival (PFS) at 6 months;
- In vivo expansion and persistence kinetics of infused CD19/CD20 CAR/TRuC-T cells.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR/TRuC-T | Experimental | Combination Product: CAR/TRuC-T |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Aged 18 to 75 years, regardless of sex;
- Histologically confirmed relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;
- ECOG performance status of 0-2;
- Expected survival of at least 3 months;
- CD20 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CAR/TRuC-TParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20 CAR/TRuC-T cell infusion. The CAR/TRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy. | Combination product | CAR/TRuC-T |
Primary outcome
TEAEs
Time frame: From date of initial treatment to the 30 days after treatment
Adverse events during treatment
1 secondary outcome
Disease-related clinical responses
Time frame: From date of enrollment until the date of clinical responses,up to 2 years
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 2 Apr 2026.
- Individual participant dataSharing planned: No
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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 Phase 1/2 study testing CAR/TRuC-T in people with Relapsed/Refractory B-cell Lymphoma, run by Shenzhen University 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 34 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 2 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 LIXIN LI, PHD (0755-21839999, wanglixin1991@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAEs (time frame: From date of initial treatment to the 30 days after treatment). 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 2 Apr 2026.