Large B-Cell Lymphoma (LBCL)Phase 2NCT07774234
Sonrotoclax, Glofitamab, Gemcitabine, and Oxaliplatin for Relapsed or Refractory Large B-Cell Lymphoma
A Phase 2 study testing Sonrotoclax, Glofitamab and Gemcitabine (1000 mg/m2) in people with Large B-Cell Lymphoma (LBCL) and High-grade B-cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This investigator-initiated, single-center, single-arm, open-label Phase II study will evaluate the efficacy and safety of sonrotoclax in combination with glofitamab, gemcitabine, and oxaliplatin in adults with relapsed or refractory large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-Cell Lymphoma (LBCL), High-grade B-cell Lymphoma
- What is being tested?
- Sonrotoclax, Glofitamab and Gemcitabine (1000 mg/m2)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 20 Aug 2030
- 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
- Histologically confirmed CD20-positive relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS); large B-cell lymphoma transformed from an indolent B-cell lymphoma; EBV-positive large B-cell lymphoma; high-grade B-cell lymphoma; and double-hit or triple-hit lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
- At least one prior line of systemic anti-lymphoma therapy. Prior treatment should generally have included an anti-CD20 monoclonal antibody and an anthracycline, unless there was a clear contraindication or the treatment was unavailable.
- Age 18 years or older.
- At least one evaluable or measurable target lesion, defined as a lymph node lesion with a longest diameter greater than 1.5 cm or an extranodal lesion with a longest diameter greater than 1.0 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function, including left ventricular ejection fraction (LVEF) of at least 50%; creatinine clearance of at least 50 mL/min, although a minimum of 40 mL/min may be acceptable if the investigator determines that treatment can be administered safely; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 3 × the upper limit of normal (ULN), or no greater than 5 × ULN in the presence of hepatic involvement; total bilirubin no greater than 1.5 × ULN, or no greater than 3 × ULN in participants with Gilbert syndrome or hepatobiliary involvement; and corrected electrolytes and tumor lysis syndrome-related laboratory parameters considered suitable for treatment.
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- Adequate hematologic function, including absolute neutrophil count (ANC) of at least 1.0 × 10^9/L, platelet count of at least 50 × 10^9/L, and hemoglobin of at least 60 g/L. Transfusion support to meet these criteria is permitted. Participants with cytopenias attributable to bone marrow involvement by lymphoma are exempt from these hematologic requirements.
- A negative pregnancy test for women of childbearing potential. Male and female participants must agree to use effective contraception during study treatment and for the protocol-specified period after the last dose of study treatment.
- Estimated life expectancy greater than 3 months.
- Ability and willingness to provide written informed consent and comply with the study protocol.
Who cannot join
- Previous central nervous system involvement by lymphoma, including involvement of the brain parenchyma, meninges, cerebrospinal fluid, spinal cord, or intraocular structures.
- Major surgery or serious trauma within 2 weeks before enrollment, or clinically significant treatment-related adverse effects that have not adequately recovered.
- History of cerebral infarction or intracranial hemorrhage within 3 months before enrollment.
- Prior treatment with glofitamab.
- Documented disease progression during or after prior treatment with a BCL-2 inhibitor when, in the investigator's judgment, the participant is unlikely to derive benefit from sonrotoclax.
- Severe hypersensitivity to glofitamab, obinutuzumab, gemcitabine, oxaliplatin, sonrotoclax, or any of their excipients.
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- Active infection that, in the investigator's judgment, cannot be adequately controlled.
- Human immunodeficiency virus (HIV) infection or inadequately controlled active hepatitis B virus or hepatitis C virus infection.
- Failure to meet the required washout period from prior antitumor therapy, including chemotherapy, radiotherapy, or antibody-drug conjugate therapy within 2 weeks or within 5 half-lives; monoclonal antibody or bispecific antibody therapy within 4 weeks; CAR T-cell therapy within 30 days; or autologous stem cell transplantation within 3 months. Prior allogeneic stem cell transplantation or active graft-versus-host disease is also exclusionary.
- High and inadequately controlled risk of tumor lysis syndrome before enrollment.
- Severe cardiovascular or pulmonary disease, including New York Heart Association Class III-IV heart failure, myocardial infarction within 6 months, unstable arrhythmia or angina, severe chronic obstructive pulmonary disease, active pneumonia, requirement for long-term supplemental oxygen, or resting oxygen saturation of 90% or lower.
- Current malignancy or another malignancy diagnosed within 3 years before enrollment, except for cured low-risk malignancies.
- Use of systemic corticosteroids equivalent to prednisone greater than 20 mg/day within 2 weeks before enrollment when the dose cannot be reduced to an acceptable level.
- Active bleeding, coagulation disorder, or an unacceptable bleeding risk as determined by the investigator.
- Pregnancy or breastfeeding, or plans to become pregnant or father a child during the study period.
- Psychiatric illness, cognitive impairment, drug or alcohol dependence, or any other factor that may interfere with understanding the study, providing informed consent, or complying with study procedures and follow-up.
- Any other condition that, in the investigator's judgment, may compromise participant safety, interfere with study conduct, or confound interpretation of study data.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Ting Xu, +86 151 6247 6547, xt21132075@163.com
About this study
Official title: A Single-Center, Single-Arm, Open-Label, Phase II Clinical Trial of Sonrotoclax, Glofitamab, Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Large B-Cell Lymphoma
This investigator-initiated, single-center, single-arm, open-label Phase II study will evaluate the efficacy and safety of sonrotoclax in combination with glofitamab, gemcitabine, and oxaliplatin in adults with relapsed or refractory large B-cell lymphoma. Participants will receive six 21-day cycles of glofitamab, gemcitabine, oxaliplatin, and sonrotoclax, followed by six 21-day cycles of glofitamab and sonrotoclax. The primary objective is to evaluate the complete response rate at the end of Cycle 6 according to the Lugano 2014 criteria. The study plans to enroll 39 participants.
- Being tested
- Sonrotoclax, Glofitamab, Gemcitabine (1000 mg/m2), Oxaliplatin, Obinutuzumab
- Keywords
- Relapsed Large B-Cell Lymphoma, Refractory Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Transformed Large B-Cell Lymphoma, EBV-Positive Large B-Cell Lymphoma, High-Grade B-Cell Lymphoma, Double-Hit Lymphoma, Triple-Hit Lymphoma, BCL-2, Sonrotoclax, Glofitamab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonrotoclaxDrug
Sonrotoclax will be administered orally. In Cycle 1, participants will receive 80 mg on Day 3, 160 mg on Day 4, and 320 mg once daily on Days 5-9. During Cycles 2-12, sonrotoclax will be administered at 320 mg once daily on Days 1-5 of each 21-day cycle.
GlofitamabBiological
Glofitamab will be administered intravenously using step-up dosing: 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12.
Gemcitabine (1000 mg/m2)Drug
Gemcitabine 1000 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6.
OxaliplatinDrug
Oxaliplatin 100 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6.
ObinutuzumabBiological
Obinutuzumab 1000 mg will be administered intravenously once on Cycle 1 Day 1 as pretreatment before glofitamab administration to reduce the risk of cytokine release syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Sonrotoclax + Glofitamab + GemOx | Experimental | Participants will receive 12 treatment cycles, each lasting 21 days. During Cycles 1-6, participants will receive sonrotoclax, glofitamab, gemcitabine, and oxaliplatin. During Cycles 7-12, participants will receive sonrotoclax and glofitamab. Obinutuzumab will be administered once on Cycle 1 Day 1 as pretreatment before glofitamab step-up dosing. Receives: Drug: Sonrotoclax; Biological: Glofitamab; Drug: Gemcitabine (1000 mg/m2); Drug: Oxaliplatin; Biological: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR) at the End of Induction Treatment
The percentage of participants who achieve a complete response (CR) according to the Lugano 2014 criteria at the end of Cycle 6. Participants who discontinue treatment early because of disease progression or death will be considered non-responders.
Measured: At the end of Cycle 6 (approximately Week 18)
Secondary outcomes (6)
Objective Response Rate (ORR)
The percentage of participants whose best overall response is complete response (CR) or partial response (PR) according to the Lugano 2014 criteria.
Measured: From the first dose of study treatment through completion of study treatment, up to approximately 44 weeks
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first. Participants without disease progression or death will be censored at the date of the last valid tumor assessment.
Measured: From the first dose of study treatment until disease progression or death from any cause, up to 48 months
Overall Survival (OS)
Overall survival is defined as the time from the first dose of study treatment to death from any cause. Participants who are alive will be censored at the date they were last known to be alive.
Measured: From the first dose of study treatment until death from any cause, up to 48 months
Duration of Response (DOR)
Among participants who achieve a complete response (CR) or partial response (PR), duration of response is defined as the time from the first documented response to the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the first documented CR or PR until disease progression or death from any cause, up to 48 months
Duration of Complete Response (DoCR)
Response (DoCR)Among participants who achieve a complete response (CR), duration of complete response is defined as the time from the first documented CR to the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the first documented CR until disease progression or death from any cause, up to 48 months
Incidence and Severity of Adverse Events
of Adverse EventsThe incidence, type, and severity of adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events, adverse events leading to treatment interruption, dose reduction or discontinuation, and treatment-related deaths will be assessed. Adverse events will be graded according to NCI CTCAE Version 6.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to ASTCT criteria.
Measured: From informed consent through 28 ± 7 days after the last dose of study treatment; selected toxicities will be followed until resolution or stabilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion20 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-Cell Lymphoma (LBCL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting Xu, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774234
- Sponsor's protocol ID
- 2026964
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Open-Label, Phase II Clinical Trial of Sonrotoclax, Glofitamab, Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07774234
- Acronym / sponsor ID
- 2026964
- Keywords
- Relapsed Large B-Cell Lymphoma, Refractory Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Transformed Large B-Cell Lymphoma, EBV-Positive Large B-Cell Lymphoma, High-Grade B-Cell Lymphoma, Double-Hit Lymphoma, Triple-Hit Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 20 Aug 2030 (estimated)
- First posted
- 19 Aug 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.
This investigator-initiated, single-center, single-arm, open-label Phase II study will evaluate the efficacy and safety of sonrotoclax in combination with glofitamab, gemcitabine, and oxaliplatin in adults with relapsed or refractory large B-cell lymphoma. Participants will receive six 21-day cycles of glofitamab, gemcitabine, oxaliplatin, and sonrotoclax, followed by six 21-day cycles of glofitamab and sonrotoclax. The primary objective is to evaluate the complete response rate at the end of Cycle 6 according to the Lugano 2014 criteria. The study plans to enroll 39 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonrotoclax + Glofitamab + GemOx | Experimental | Drug: Sonrotoclax, Biological: Glofitamab, Drug: Gemcitabine (1000 mg/m2), Drug: Oxaliplatin, Biological: ObinutuzumabParticipants will receive 12 treatment cycles, each lasting 21 days. During Cycles 1-6, participants will receive sonrotoclax, glofitamab, gemcitabine, and oxaliplatin. During Cycles 7-12, participants will receive sonrotoclax and glofitamab. Obinutuzumab will be administered once on Cycle 1 Day 1 as pretreatment before glofitamab step-up dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed CD20-positive relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS); large B-cell lymphoma transformed from an indolent B-cell lymphoma; EBV-positive large B-cell lymphoma; high-grade B-cell lymphoma; and double-hit or triple-hit lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
- At least one prior line of systemic anti-lymphoma therapy. Prior treatment should generally have included an anti-CD20 monoclonal antibody and an anthracycline, unless there was a clear contraindication or the treatment was unavailable.
- Age 18 years or older.
- At least one evaluable or measurable target lesion, defined as a lymph node lesion with a longest diameter greater than 1.5 cm or an extranodal lesion with a longest diameter greater than 1.0 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (17 listed)
- Previous central nervous system involvement by lymphoma, including involvement of the brain parenchyma, meninges, cerebrospinal fluid, spinal cord, or intraocular structures.
- Major surgery or serious trauma within 2 weeks before enrollment, or clinically significant treatment-related adverse effects that have not adequately recovered.
- History of cerebral infarction or intracranial hemorrhage within 3 months before enrollment.
- Prior treatment with glofitamab.
- Documented disease progression during or after prior treatment with a BCL-2 inhibitor when, in the investigator's judgment, the participant is unlikely to derive benefit from sonrotoclax.
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 |
|---|---|---|
| SonrotoclaxSonrotoclax will be administered orally. In Cycle 1, participants will receive 80 mg on Day 3, 160 mg on Day 4, and 320 mg once daily on Days 5-9. During Cycles 2-12, sonrotoclax will be administered at 320 mg once daily on Days 1-5 of each 21-day cycle. | Drug | Sonrotoclax + Glofitamab + GemOx |
| GlofitamabGlofitamab will be administered intravenously using step-up dosing: 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12. | Biological | Sonrotoclax + Glofitamab + GemOx |
| Gemcitabine (1000 mg/m2)Gemcitabine 1000 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6. | Drug | Sonrotoclax + Glofitamab + GemOx |
| OxaliplatinOxaliplatin 100 mg/m² will be administered intravenously on Cycle 1 Day 2 and on Day 1 of Cycles 2-6. | Drug | Sonrotoclax + Glofitamab + GemOx |
| ObinutuzumabObinutuzumab 1000 mg will be administered intravenously once on Cycle 1 Day 1 as pretreatment before glofitamab administration to reduce the risk of cytokine release syndrome. | Biological | Sonrotoclax + Glofitamab + GemOx |
Primary outcome
Complete Response Rate (CRR) at the End of Induction Treatment
Time frame: At the end of Cycle 6 (approximately Week 18)
The percentage of participants who achieve a complete response (CR) according to the Lugano 2014 criteria at the end of Cycle 6. Participants who discontinue treatment early because of disease progression or death will be considered non-responders.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment through completion of study treatment, up to approximately 44 weeks
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until disease progression or death from any cause, up to 48 months
Overall Survival (OS)
Time frame: From the first dose of study treatment until death from any cause, up to 48 months
Duration of Response (DOR)
Time frame: From the first documented CR or PR until disease progression or death from any cause, up to 48 months
Duration of Complete Response (DoCR)
Time frame: From the first documented CR until disease progression or death from any cause, up to 48 months
Incidence and Severity of Adverse Events
Time frame: From informed consent through 28 ± 7 days after the last dose of study treatment; selected toxicities will be followed until resolution or stabilization
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ting Xu principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sonrotoclax, Glofitamab and Gemcitabine (1000 mg/m2) in people with Large B-Cell Lymphoma (LBCL) and High-grade B-cell Lymphoma, run by The First Affiliated Hospital of Soochow University 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 10 inclusion and 17 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 19 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 Ting Xu (+86 151 6247 6547, xt21132075@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 (CRR) at the End of Induction Treatment (time frame: At the end of Cycle 6 (approximately Week 18)). 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 19 Aug 2026.