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DLBCL - Diffuse Large B Cell LymphomaPhase 2NCT07326371

Glofitamab Combined With CAR-T Therapy in R/R DLBCL

A Phase 2 study testing Glofitamab, Obinutuzumab and Axicabtagene Ciloleucel in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Ruijin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study is a single-center, open-label, prospective study aimed at evaluating the efficacy and safety of Glofitamab combined with CAR-T therapy in patients with high-risk relapsed/refractory large B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL - Diffuse Large B Cell Lymphoma
What is being tested?
Glofitamab, Obinutuzumab and Axicabtagene Ciloleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Mar 2026to Mar 2029
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • Histologically confirmed large B==cell lymphoma with CD19 and CD20 expression, including diffuse large B==cell lymphoma (DLBCL) not otherwise specified (NOS); primary mediastinal large B==cell lymphoma (PMBCL); high==grade B==cell lymphoma (HGBL); and DLBCL transformed from follicular lymphoma
  • Patients who have relapsed after at least one prior line of therapy or are refractory, including those who have received anthracycline==containing chemotherapy regimens and anti==CD20 monoclonal antibody therapy
  • Patients must be willing to receive CAR==T and Glofitamab therapy and be deemed suitable for CAR==T and Glofitamab treatment by the investigator
  • Presence of at least one high==risk prognostic factor: (1) extranodal involvement; (2) maximum tumor diameter > 4 cm; (3) TP53 mutation
  • No CNS involvement
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  • ECOG Performance Status of 0, 1, or 2
  • Life expectancy ≥12 weeks
  • Adequate hematologic function (unless due to underlying disease, such as extensive bone marrow involvement, or secondary to lymphoma==related splenomegaly as determined by the investigator, but transfusion of blood products is allowed) and adequate liver, renal, pulmonary, and cardiac function, defined as follows:
  • Neutrophil count ≥ 1.0 × 10^9/L, platelet count ≥ 50 × 10^9/L, lymphocyte count ≥ 0.1 × 10^9/L
  • ALT/AST ≤ 2.5 × ULN and total bilirubin < 1.5 × ULN (except for participants with Gilbert's syndrome or lymphoma involvement of the liver)
  • Creatinine clearance ≥ 30 mL/min
  • Pulmonary function: ≤ CTCAE grade 1 dyspnea, oxygen saturation (SpO2) ≥ 92% on room air
  • Cardiac function: LVEF ≥ 40%
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiating study treatment. Women who are postmenopausal (defined as no menses for ≥ 12 months without an alternative medical cause) or have undergone surgical sterilization (removal of ovaries and/or uterus) are not required to undergo a pregnancy test
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm
  • Patients with a distant history of autoimmune disease or well==controlled autoimmune disease may be eligible for enrollment at the investigator's discretion
  • Patients with a history of autoimmune==related hypothyroidism who are on a stable dose of thyroid replacement hormone may be eligible for this study
  • Patients with a history of disease==related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study
  • Patients with a history of type 1 diabetes mellitus who are well controlled (defined as hemoglobin A1c < 8% at screening and no episodes of diabetic ketoacidosis) are eligible for this study
  • Patients with eczema, psoriasis, chronic lichen simplex, or vitiligo with only skin involvement (e.g., excluding psoriatic arthritis) are eligible for this study if they meet all of the following conditions： Rash must cover < 10% of body surface area The disease is well controlled at baseline and only requires low==potency topical corticosteroids No acute exacerbations of an underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologics, oral calcineurin inhibitors, or high==potency oral corticosteroids within the past 12 months
  • Subjects with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as determined by the investigator, may participate in this study

Who cannot join

  • History of allergic reactions to compounds with similar chemical or biological composition to axi==cel, relma==cel, glofitamab, obinutuzumab, or other drugs used in the study.
  • Active or uncontrolled infections requiring systemic therapy (including fungal, bacterial, viral, etc.)
  • History of allogeneic hematopoietic stem cell transplantation
  • History of organ transplantation
  • Viral infections deemed uncontrollable by antiviral medications, as determined by the investigator, including:
  • Active hepatitis B virus (HBV) infection with HBV DNA ≥ 500 IU/mL (2500 copies/mL)
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  • Positive hepatitis C virus (HCV) RNA test
  • Positive human immunodeficiency virus antibody (HIV==Ab) test
  • Positive Treponema pallidum antibody (TP==Ab) test
  • Cytomegalovirus (CMV) DNA levels above the upper limit of normal
  • Epstein==Barr virus (EBV) DNA levels above the upper limit of normal
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Presence of brain metastases or active primary central nervous system lymphoma
  • Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
  • Presence of severe genetic disorders or severe autoimmune diseases, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome==associated vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain==Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Thromboembolic events (e.g., myocardial infarction, pulmonary embolism, deep vein thrombosis, or other systemic embolic events) within 6 months prior to screening
  • Malignancies other than the indication for this trial within 5 years prior to screening, except for in situ cancers (e.g., cervical, bladder, breast) or non==melanoma skin cancers
  • Receipt of chemotherapy drugs, tumor radiotherapy, or immunosuppressive antibodies such as anti==TNF, anti==IL6, or anti==IL6R within 4 weeks or 5 half==lives (whichever is shorter) prior to mononuclear cell collection
  • Vaccination with live, attenuated vaccines within 3 months prior to mononuclear cell collection, or expected need for such vaccination during the trial
  • Currently pregnant or breastfeeding, or planning to become pregnant during the study or within 12 months after the last dose
  • Patients currently participating in other clinical trials (e.g., new drug clinical trials, registration studies, investigator==initiated clinical studies)
  • Deemed unsuitable for this clinical trial by the investigator (e.g., poor compliance, substance abuse)
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the study protocol or interpretation of results
  • Any other diseases, metabolic dysfunctions, physical examination findings, or clinical laboratory results that reasonably suggest the presence of a condition that contraindicates the use of the investigational drug

About this study

Official title: A Single-Center, Prospective Study Evaluating the Efficacy and Safety of Glofitamab Combined With CAR-T Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma

This study is a single-center, open-label, prospective study aimed at evaluating the efficacy and safety of Glofitamab combined with CAR-T therapy in patients with high-risk relapsed/refractory large B-cell lymphoma.

Being tested
Glofitamab, Obinutuzumab, Axicabtagene Ciloleucel, Relmacabtagene autoleucel (relma-cel)
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

    Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.

  • ObinutuzumabDrug

    Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.

  • Axicabtagene CiloleucelDrug

    Axicabtagene Ciloleucel IV infusion will be administered as per the schedule specified in the respective arm.

  • Relmacabtagene autoleucel (relma-cel)Drug

    Relmacabtagene autoleucel IV infusion will be administered as per the schedule specified in the respective arm.

Study groups in NCT07326371
Study groupRoleWhat they receive
Glofit_CARTExperimentalAfter undergoing leukapheresis, patients will receive treatment in three phases: the bridging phase, the CAR-T treatment phase, and the consolidation phase. Bridging Phase: All patients will receive two cycles of Glofitamab treatment. On Day 1 of Cycle 1, patients will receive 1000 mg of Obinutuzumab as pretreatment. After the completion of Cycle 2, patients will undergo an assessment. CAR-T Treatment Phase: Participants will receive lymphodepletion therapy with the FLU/CY regimen from Day -5 to Day -3. On Day 0, patients will receive the CAR-T cell infusion. Consolidation Phase: Based on the efficacy assessment on Day 28, the subsequent treatment plan will be determined: Patients achieving complete response (CR) will not receive additional Glofitamab treatment. Patients with partial response (PR), stable disease (SD), or progressive disease (PD) will continue to receive Glofitamab treatment for four additional cycles.
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: Axicabtagene Ciloleucel; Drug: Relmacabtagene autoleucel (relma-cel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate (CRR)

    Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: Baseline up to the end of treatment (EOT) (approximately 4 months)

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: Baseline up to the EOT (approximately 4 months)

  2. Duration of Response (DoR)

    Measured: From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 42 months)

  3. PFS

    Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: From the start of treatment until the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (approximately 42 months)

  4. Overall Survival (OS)

    Measured: From the start of treatment until the date of death from any cause (approximately 42 months)

  5. Number of Participants with TEAEs

    Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 grading scale, including CRS, with severity determined according to the ASTCT CRS grading criteria

    Measured: Up to the end of the study (approximately 42 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionMar 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07326371
Sponsor's protocol ID
Glofit_peri_CART
Status last verified
Jul 2025
First submitted
26 Dec 2025
Last updated
8 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glofitamab, Obinutuzumab and Axicabtagene Ciloleucel in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Ruijin Hospital.

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 23 inclusion and 25 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (CRR) (time frame: Baseline up to the end of treatment (EOT) (approximately 4 months)). 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 NCT07326371.

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 8 Jan 2026.

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