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Diffuse Large B-Cell Lymphoma-RecurrentPhase 2NCT06570447

Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

A Phase 2 study testing Glofitamab and Chidamide in people with Diffuse Large B-Cell Lymphoma-Recurrent and Diffuse Large B-Cell Lymphoma-Refractory, run by Tianjin Medical University Cancer Institute and Hospital 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
Search all trials

Trial summary

An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Glofitamab and Chidamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
27 Feb 2025to 31 Dec 2028
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

  • To be eligible for enrollment in this study, a subject must meet all of the following criteria:
  • Signed informed consent
  • Age ≥ 18 years at the time of informed consent
  • Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients must also be willing to comply with all study-related procedures.
  • Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis: DLBCL-NOS, HGBCL, PMBCL and FL transformed DLBCL (trFL)
  • A pathology report (if available) from the initial histopathological diagnosis must be provided. Patients with trFL must also provide a pathology report (if available) at the time of disease transformation. Results of all tissue tests performed at initial diagnosis should be provided, including but not limited to tests to assess cellular origin, BCL2, and MYC abnormalities (if performed).
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  • Patients must have relapsed or Cap following at least two prior lines of systemic therapy (including at least one prior regimen containing anthracene Treatment failure and at least one prior regimen containing anti-CD20 targeted therapy).
  • Patients may have received Autologous haematopoietic stem cell transplant (HSCT) prior to recruitment; consolidative autologous HSCT after Chemotherapy will be counted as a line of therapy.
  • CAR T cells plus bridging were counted as a treatment line.
  • Local therapies (e.g., radiotherapy) will not be considered as treatment lines.
  • Patients must have measurable disease: at least one bidimensionally measurable Lymphadenopathy, defined as > 1.5 cm in the longest diameter; or at least one bidimensionally measurable extranodal lesion, defined as > 1.0 cm in the longest diameter.
  • Verify availability of Neoplasm tissues, unless not available per investigator assessment. Freshly collected Biopsy specimens are preferred. Representative Neoplasm tissue specimens or unstained serial sections are acceptable.
  • Eastern Cooperative Neoplasm Group (ECOG) performance status of 0 or 1
  • Life expectancy (as assessed by the investigator) ≥ 12 weeks
  • Carcinoma due to prior anti Adverse event therapy must have resolved to ≤ grade 1 (except Alopecia and Hyporexia).
  • Adequate liver function
  • Bilirubin total ≤ 1.5 x upper limit of normal (ULN); patients with documented history of Gilbert's syndrome: Bilirubin total ≤ 3 x ULN with elevated indirect Bilirubin;
  • AST/ALT ≤ 3 × ULN
  • Adequate hematological function:
  • Neutrophil count ≥ 1.5 x 109 cells/L (1.500/μL);
  • Platelet count ≥ 75,000/μL (and no Platelet transfusion within 14 days before Gpt administration on Day 1 of Cycle 1);
  • Haemoglobin ≥ 10.0 g/dL (6.2 mmol/L); no Transfusion within 21 days prior to Gpt dosing on Cycle 1 Day 1
  • Adequate renal function: Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL/min calculated according to the C OC kroft Gault formula (see Appendix 14) (patients whose renal function is not adequately reflected by Serum creatinine levels as judged by the investigator)
  • Negative serum Pregnancy test within 7 days prior to study treatment for women of childbearing potential. Amenorrhoea is not required for women of non-childbearing potential who are post-menopausal (≥ 12 months of non-therapeutic Surgery) or Pregnancy test sterilized (absence of ovaries and/or uterus). For women of childbearing potential: Agree to remain abstinent (avoid heterosexual intercourse) or to take Contraception measures.
  • For men: Agree to remain abstinent (avoid heterosexual intercourse) or practice Contraception

Who cannot join

  • Any subject who meets any of the following criteria should not be enrolled in the study:
  • Inability to comply with protocol-specified hospitalization and restrictions
  • Richter's transformation
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other Infection (excluding Nail bed infection fungal) at study entry or any major Infection (as evaluated by the investigators) within 4 weeks prior to first study treatment Contacts and Locations
  • Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)
  • Positive test result for Chronic hepatitis B virus (HBV) Infection (defined as positive Hepatitis B surface antigen [HBsAg] serology).
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  • Patients with occult or previous HBV Infection (defined as HBsAg negative and Hepatitis B core antibody [HBcAb] positive) may be included if HBV DNA is undetectable, provided they are willing to undergo HBV DNA testing monthly during study treatment (or on Day 1 of each cycle) and monthly for at least 12 months after the last cycle, and are willing to receive appropriate antiviral therapy.
  • Positive Hepatitis C virus (HCV) Antibody test
  • Patients with HCV Polymerase chain reaction are eligible only if the PCR (Antibody positive) is negative for HCV RNA.
  • Known HIV seropositive status
  • For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations.
  • Known or suspected chronic active Epstein-Barr Viral infection
  • Known or suspected history of Haemophagocytic lymphohistiocytosis (H LH)
  • Pregnancy or lactating, or planning to Pregnancy during treatment and for at least 3 months after the last dose of Gpt or within 2 months after the last dose of Glofitamab
  • A history of treatment-emergent Immunization related Immunization associated with prior Adverse event treatment agents as follows:
  • Grade 3 Adverse event, except for Grade 3 endocrinopathy managed with alternative therapy
  • Grade 1-2 Adverse event that did not return to baseline after Therapy cessation
  • Documented refractory to Obinutuzumab monotherapy
  • Active autoimmune disease requiring treatment requires investigator assessment of Immunization
  • Evidence of significant, uncontrolled concomitant disease that could affect adherence to the study protocol or interpretation of results, including Immunization, relevant Lung disorder history (Bronchospasm, Obstruction Pneumopathy), and known autoimmune Diabetes mellitus
  • History of severe Allergy or Allergic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion Protein)
  • History of confirmed progressive multifocal Leukoencephalopathy (PML)
  • Current or past history of CNS Lymphoma
  • Current or past history of CNS disease such as Stroke, Epilepsy, CNS Vasculitis, or neurodegenerative disease
  • Another invasive Neoplasm malignant within the last 2 years (except Basal cell carcinoma and Neoplasm with a low likelihood of recurrence)
  • Serious or extensive Angina unstable such as New York Heart disorder Association Class III or IV or objectively assessed Class C or D Cardiac disorder, Myocardial infarction within the last 6 months, unstable Arrhythmia, or Cardiovascular disorder
  • Administration of a live attenuated vaccine within 4 weeks prior to Gpt infusion, or anticipated need for a live attenuated vaccine during the study. ( Note: Flu vaccination should only be administered during the Flu season. Patients must not receive live attenuated Flu vaccine at any time during study treatment.)
  • Systemic Tumour necrosis agents (including but not limited to Cap Phosphorus amide, thiazolyl Purines, methotrexate, thalidomide, and anti Ammonia factor agents) within 2 weeks prior to Gpt infusions
  • Corticosteroid therapy with ≤ 25 mg/day prednisone or equivalent is allowed.
  • Inhaled and topical steroids are allowed.
  • History of illicit drugs or Alcohol abuse within 12 months prior to screening, as judged by the investigators.
  • Any other disease, metabolic dysfunction, Physical examination result, or clinical lab result reasonably suspecting a disease or condition that contraindicates the use of an investigational drug
  • Investigators should review the Vaccination status of potential study patients considered for this study and follow local disease control and prevention guidelines for vaccination of any other non-live vaccinated adults aiming to prevent infectious diseases prior to the study.
  • Any mental or Cognitive disorder that would limit the understanding, conduct, and compliance with the informed consent form;
  • Pregnancy or lactating females, or females or male partners planning to Pregnancy during the study;
  • Other situations that the investigators consider Discomfort to be eligible for this trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huilai Zhang contact

+86-18622221228

huilaizhangtz@163.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Insititute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Zhang Huilai, PHD, 086-02223340123, zhlwgq@126.com

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma

An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.

Read the detailed description

This is an open-label, single-arm, single-center study to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in the patient ≥ 18 years of age with recurrent/refractory diffuse large B-cell lymphoma. Subjects who meet the eligibility criteria will receive combination therapy of Glofitamab, chidamide. The study will include the following sequential phases: screening, treatment, and follow-up.

Being tested
Glofitamab, Chidamide

What participants receive

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

  • GlofitamabDrug

    For Glofitamab Injection solution, after Obinutuzumab pretreatment on Day 1 of Cycle 1, patients followed a step-dose escalation regimen.

  • ChidamideDrug

    Chidamide: 20 mg/d orally twice a week for 21 days as a treatment cycle.

Study groups in NCT06570447
Study groupRoleWhat they receive
combination therapy of Glofitamab, chidamideExperimentalEach subject will be given combination therapy of Glofitamab, chidamide. Glofitamab Injection with 2.5 mg on D8 and 10 mg on D15 in Cycle 1; with 30mg in Cycle 2-12, every 3 weeks.
Receives: Drug: Glofitamab; Drug: Chidamide

What is being measured

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

  1. complete response rate (CR)

    To assess the complete response rate (CR) at the end of treatment with Glofitamab combination with chidamide.

    Measured: up to the end of 12 cycles of treatment (each cycle is 28 days)

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment of Glofitamab combination with chidamide.

    Measured: up to the end of 12 cycles of treatment (each cycle is 28 days)

  2. Duration of Response (DoR)

    The length of time between the achievement of criteria for response to treatment (first documented complete or partial response) and the first documented relapse or progression.

    Measured: up to 2 years

  3. Progression-free survival (PFS)

    The time from the enrollment of a subject to the occurrence of (in any way) progression of disease or Death for any reason. patients with indeterminate recurrence or Death at the last follow-up, defined as the date of the last Investigation

    Measured: up to 2 years

  4. OS

    The time from subject enrollment to Death caused by any reason. for patients lost to follow-up, the time of the last follow-up; for patients still alive at the end of study, the date of the end of follow-up.

    Measured: 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.

  1. First posted26 Aug 2024
  2. Study start27 Feb 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570447
Sponsor's protocol ID
GTC-RR-DLBCL01
Status last verified
Jul 2026
First submitted
11 Aug 2024
Last updated
3 Aug 2026
Results posted
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 2 study testing Glofitamab and Chidamide in people with Diffuse Large B-Cell Lymphoma-Recurrent and Diffuse Large B-Cell Lymphoma-Refractory, run by Tianjin Medical University Cancer Institute and 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 25 inclusion and 36 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 3 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 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?

Contact Huilai Zhang (+86-18622221228, huilaizhangtz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response rate (CR) (time frame: up to the end of 12 cycles of treatment (each cycle is 28 days)). 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 NCT06570447.

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 3 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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