Relapsed/Refractory Large B-cell Lymphoma (LBCL)Phase 1/2NCT07788118
A Phase Ib/II Exploratory Clinical Trial of Memory-Enhanced 7×19-THEMIS CAR-T Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma
A Phase 1/2 study testing 7×19-THEMIS CAR-T cells in people with Relapsed/Refractory Large B-cell Lymphoma (LBCL) and Diffuse Large B-Cell Lymphoma (DLBCL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is aimed to explored the safety and efficacy of 7×19-THEMIS CAR-T cell therapy for large B-cell lymphoma and to conduct an exploratory comparison of the 3-month objective response rate (ORR) and complete remission rate (CR rate) between the experimental cohort and the historical control cohort (NCT04833504). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Large B-cell Lymphoma (LBCL), Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- What is being tested?
- 7×19-THEMIS CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2031
- Phase
- Phase 1/2
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
- Voluntarily participate in this study and sign the informed consent form.
- Age range: 18 - 75 years old. Gender is not restricted.
- Histologically confirmed large B-cell lymphoma, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL), and mantle cell lymphoma (MCL).
- CD19-positive (as determined by immunohistochemistry or flow cytometry; based on the most recent tumor biopsy results).
- Definition of relapsed/refractory: Failure to achieve complete remission (CR) after at least two lines of therapy (which must include a CD20 monoclonal antibody and an anthracycline); or disease progression during any course of treatment; or relapse/progression within 12 months after autologous hematopoietic stem cell transplantation.
- At least one measurable lesion: any lymph node lesion with a longest dimension >1.5 cm, or any extranodal lesion with a longest dimension >1.0 cm, and the lesion shows uptake on PET-CT (SUV greater than the hepatic pool).
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- Absolute neutrophil count in peripheral blood ≥ 1,000/μL; platelet count ≥ 45,000/μL.
- Cardiac, hepatic, and renal function: creatinine < 1.5 mg/dL; ALT/AST ≤ 2.5 times the upper limit of normal; total bilirubin < 1.5 mg/dL; ejection fraction ≥ 50%.
- Possess sufficient cognitive capacity to voluntarily sign the informed consent form.
- Participants of reproductive potential must be willing to use effective contraception (from the time of signing the informed consent form until 12 months after CAR-T infusion).
- The investigator estimates a life expectancy of at least 4 months.
- Willing to comply with the schedule of visits, dosing regimen, laboratory tests, and other trial procedures.
Who cannot join
- History of other malignant tumors (excluding cured basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc.).
- Autologous hematopoietic stem cell transplantation within the past 6 weeks.
- Any targeted CAR-T therapy within 3 months prior to this CAR-T treatment.
- Patients who have previously received PD-1 monoclonal antibodies must have a washout period of ≥3 months before enrollment.
- Received cytotoxic drugs, glucocorticoids (except for prednisone-equivalent doses of ≤10 mg/day), or other targeted therapies within 2 weeks prior to cell collection.
- Active autoimmune diseases (e.g., systemic lupus erythematosus, inflammatory bowel disease, etc.).
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- Uncontrolled active bacterial, fungal, or viral infections.
- HIV infection, syphilis; active hepatitis B or C: Hepatitis B: HBsAg-positive and HBV-DNA ≥ 1,000 IU/mL; Hepatitis C: HCV RNA-positive and abnormal liver function.
- Known central nervous system lymphoma (confirmed by brain MRI or CT and cerebrospinal fluid examination).
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
The Second Affiliated Hospital,School of Medicine,Zhejiang University, Hangzhou, Zhejiang 310009
Hangzhou, Zhejiang, 310009
Wenbin Qian,Professor, +86 13605801032, qianwb@zju.edu.cn
Wen Lei,Doctor, +86 18258448016, leiwen2017@zju.edu.cn
About this study
Official title: A Phase Ib/II Exploratory Clinical Trial of Memory-Enhanced 7×19-THEMIS CAR-T Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma: A Single-Arm Design Using a Historical Control (7×19 CAR-T)
This study is aimed to explored the safety and efficacy of 7×19-THEMIS CAR-T cell therapy for large B-cell lymphoma and to conduct an exploratory comparison of the 3-month objective response rate (ORR) and complete remission rate (CR rate) between the experimental cohort and the historical control cohort (NCT04833504).
- Conditions
- Relapsed/Refractory Large B-cell Lymphoma (LBCL), Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Transforming Follicular Lymphoma (tFL), Mantle Cell Lymphoma (MCL)
- Being tested
- 7×19-THEMIS CAR-T cells
- Medical subject headings
- Recurrence, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7×19-THEMIS CAR-T cellsBiological
IL7 and CCL19 Armed anti-CD19 CAR-T with coexpressing Themis
| Study group | Role | What they receive |
|---|---|---|
| 7×19-THEMIS CAR-T | Experimental | A single dose intravenous injection of 7X19-Themis at day 0 Receives: Biological: 7×19-THEMIS CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Recommended Phase II Dose (RP2D)
Based on the incidence of DLTs, CAR-T cell kinetics, preliminary efficacy, and safety data from the Phase Ib dose-escalation phase, the Safety Review Committee (SRC) determined the RP2D following a comprehensive evaluation.
Measured: Up to 3 months
Objective Response Rate (ORR)
At 3 months (±7 days) after infusion, the proportion of patients achieving complete remission (CR) or partial remission (PR) was assessed according to the Lugano 2014 criteria, and a descriptive comparison was made with the historical control cohort.
Measured: Up to 3 months
Complete Remission Rate (CR Rate)
At 3 months (±7 days) after infusion, the proportion of patients who achieved complete remission (CR) was assessed according to the Lugano 2014 criteria, and a descriptive comparison was made with the historical control cohort.
Measured: Up to 3 months
Secondary outcomes (9)
Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) graded according to ASTCT 2019 criteria
The incidence and severity of CRS and ICANS will be assessed according to the American Society for Transplantation and Cellular Therapy (ASTCT) 2019 consensus grading criteria. The incidence of each grade (Grades 1-4) will be summarized, with particular attention to the incidence of Grade ≥3 CRS and Grade ≥3 ICANS.
Measured: up to 28 days
Incidence and duration of Grade ≥3 hematologic toxicities assessed according to CTCAE version 5.0
The incidence and duration of Grade ≥3 neutropenia, anemia, and thrombocytopenia will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: up to 28 days
Incidence of clinically significant infections requiring anti-infective treatment or hospitalization
The incidence of bacterial, fungal, and viral infections requiring anti-infective treatment or hospitalization will be recorded and summarized.
Measured: up to 28 days
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from CAR-T cell infusion to the first documented disease progression (PD) or death from any cause, whichever occurs first. Median PFS and PFS rates at 12 and 24 months will be estimated using the Kaplan-Meier method.
Measured: up to 2-5 years
Overall Survival (OS)
Overall survival is defined as the time from CAR-T cell infusion to death from any cause. Median OS and OS rates at 12 and 24 months will be estimated using the Kaplan-Meier method.
Measured: up to 2-5 years
Duration of Response (DOR)
Among participants who achieve complete response (CR) or partial response (PR), duration of response is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first. Median DOR will be estimated using the Kaplan-Meier method.
Measured: up to 2-5 years
In Vivo Kinetics of CAR-T Cells
Measurement of CAR-T Cell Counts in Peripheral Blood and Comparison of Kinetic Parameters
Measured: up to 2-5 years
Serum Cytokine Dynamics
Measure the concentrations of cytokines such as IL-6, IFN-γ, IL-7, and CCL19 in serum at various time points following infusion.
Measured: day-5,day4,day7,day11,day14,day18,day21,day28,month 3
B-Cell Recovery
Determine the absolute count of CD19+CD20+ cells in peripheral blood to assess the dynamics of B-cell recovery following infusion.
Measured: month1, month3, month6, month9, months12, month24, year3 and year5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Large B-cell Lymphoma (LBCL)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenbin Qian,Professor, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788118
- Sponsor's protocol ID
- 2026-0675
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No