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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
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

  • 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.

Wenbin Qian,Professor contact

+86 13605801032

qianwb@zju.edu.cn

Wen Lei,Doctor contact

+86 18258448016

leiwen2017@zju.edu.cn

China1 site, 1 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

    Recruiting

Other trials in China

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).

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 groups in NCT07788118
Study groupRoleWhat they receive
7×19-THEMIS CAR-TExperimentalA 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted26 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Sep 2031 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 12 inclusion and 9 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 26 Aug 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 Wenbin Qian,Professor (+86 13605801032, qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the Recommended Phase II Dose (RP2D) (time frame: Up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07788118.

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 Aug 2026.

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