Large B Cell Diffuse LymphomaPhase 2NCT07077512
Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
A Phase 2 study testing Autoleucel (Relmacabtagene Autoleucel) and Sintilimab (PD-1 inhibitor) in people with Large B Cell Diffuse Lymphoma and Mantle Cell Lymphoma (MCL), run by Sun Yat-sen University at 3 sites in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Large B Cell Diffuse Lymphoma, Mantle Cell Lymphoma (MCL), Follicular Lymphoma ( FL)
- What is being tested?
- Autoleucel (Relmacabtagene Autoleucel) and Sintilimab (PD-1 inhibitor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 15 Sep 2025to 15 Jul 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be aware of and voluntarily sign the informed consent form (ICF).
- Aged between 18 and 70 years, both male and female.
- Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
- The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
- Relapsed/refractory DLBCL, FL, or MCL.
- At least one measurable or evaluable lesion.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival of ≥3 months.
- Adequate function of the heart, lungs, liver, kidneys, and other organs.
Who cannot join
- History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on.
- Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
- Hepatitis C, HIV, or syphilis infection.
- Uncontrolled systemic fungal, bacterial, viral, or other infections.
- Acute or chronic graft-versus-host disease (GVHD).
- Known hypersensitivity or allergy to any study drug or excipient.
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- Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness.
- Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception.
- Mentally ill individuals or those unable to provide informed consent.
- The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol.
- Previous CAR-T cell therapy or other gene-modified T-cell treatments.
- Previous CD19-targeted therapy.
- Previous allogeneic hematopoietic stem cell transplantation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Sun Yat-sen Universitiy Cancer Center
Guangzhou, 51000
Qing qing Cai, MD. PhD, 0086-20-87342823, caiqq@sysucc.org.cn
Yi Xia, MD. PhD, 0086-20-87342823, xiayi@sysucc.org.cn
- Not yet recruiting
Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510060
Runhui Zheng, 13560225061, 332520646@qq.com
- Not yet recruiting
Guangzhou overseas Chinese hospital
Guangzhou, 510632
liye zhong, 13924200567, liye_zhong@hotmail.com
About this study
Official title: A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma
Read the detailed description
Relmacabtagene Autoleucel treatment: Patients will receive intravenous fludarabine (25 mg/m²/day for 3 days) and cyclophosphamide (250 mg/m²/day for 3 days) for lymphodepletion, with adjustments based on hematologic and renal function.Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion.
Sintilimab treatment: Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Primary endpoint: The complete response rate (CRR) at 3 months.
- Being tested
- Autoleucel (Relmacabtagene Autoleucel), Sintilimab (PD-1 inhibitor)
- Keywords
- Relmacabtagene Autoleucel, Sintilimab, CD19 Positive, B cell lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autoleucel (Relmacabtagene Autoleucel)Drug
Also called Chimeric Antigen Receptor T-Cell (CAR-T) Therapy
Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).
Sintilimab (PD-1 inhibitor)Drug
Also called PD-1 Inhibitor
Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Relmacabtagene Autoleucel in combination with Sintilimab | Experimental | Patients with CD19-positive relapsed/refractory B-cell lymphoma will receive Relmacabtagene Autoleucel after lymphodepletion therapy (fludarabine + cyclophosphamide) on Day 1. After Relmacabtagene Autoleucel infusion, sintilimab (200 mg IV) will begin on Day 28, administered every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 1 year. Receives: Drug: Autoleucel (Relmacabtagene Autoleucel); Drug: Sintilimab (PD-1 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete response rate (CRR) at 3 months
Measured: Up to 3 months after Relmacabtagene Autoleucel infusion
Secondary outcomes (5)
Disease-free survival (DFS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of the first complete response to the date of the first documented progression or death from any cause, whichever came first,assessed up to 24 months
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of the first documented progression or death from any cause,whichever came first,assessed up to 24 months
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of death from any cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
To identify the incidence of AE and SAE
Measured: Through study completion, an average of 2 years
Objective Response Rate
To investigate the preliminary anti-tumor efficacy
Measured: Up to 1 year after Relmacabtagene Autoleucel infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Sep 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jul 2027 (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 Diffuse LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou Overseas Chinese Hospital,Guangdong
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077512
- Sponsor's protocol ID
- B2025-263-01
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2025
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT07077512
- Acronym / sponsor ID
- B2025-263-01
- Keywords
- Relmacabtagene Autoleucel, Sintilimab, CD19 Positive, B cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou Overseas Chinese Hospital,Guangdong
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 22 Jul 2025 (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 is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma
Detailed description
Relmacabtagene Autoleucel treatment: Patients will receive intravenous fludarabine (25 mg/m²/day for 3 days) and cyclophosphamide (250 mg/m²/day for 3 days) for lymphodepletion, with adjustments based on hematologic and renal function.Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion.
Sintilimab treatment: Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Primary endpoint: The complete response rate (CRR) at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relmacabtagene Autoleucel in combination with Sintilimab | Experimental | Drug: Autoleucel (Relmacabtagene Autoleucel), Drug: Sintilimab (PD-1 inhibitor)Patients with CD19-positive relapsed/refractory B-cell lymphoma will receive Relmacabtagene Autoleucel after lymphodepletion therapy (fludarabine + cyclophosphamide) on Day 1. After Relmacabtagene Autoleucel infusion, sintilimab (200 mg IV) will begin on Day 28, administered every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 1 year. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must be aware of and voluntarily sign the informed consent form (ICF).
- Aged between 18 and 70 years, both male and female.
- Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
- The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
- Relapsed/refractory DLBCL, FL, or MCL.
Key exclusion criteria (13 listed)
- History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on.
- Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
- Hepatitis C, HIV, or syphilis infection.
- Uncontrolled systemic fungal, bacterial, viral, or other infections.
- Acute or chronic graft-versus-host disease (GVHD).
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 |
|---|---|---|
| Autoleucel (Relmacabtagene Autoleucel)Also: Chimeric Antigen Receptor T-Cell (CAR-T) TherapyRelmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide). | Drug | Relmacabtagene Autoleucel in combination with Sintilimab |
| Sintilimab (PD-1 inhibitor)Also: PD-1 InhibitorPatients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year. | Drug | Relmacabtagene Autoleucel in combination with Sintilimab |
Primary outcome
The complete response rate (CRR) at 3 months
Time frame: Up to 3 months after Relmacabtagene Autoleucel infusion
5 secondary outcomes
Disease-free survival (DFS)
Time frame: From the date of the first complete response to the date of the first documented progression or death from any cause, whichever came first,assessed up to 24 months
Progression-free survival (PFS)
Time frame: From the date of enrollment until the date of the first documented progression or death from any cause,whichever came first,assessed up to 24 months
Overall survival (OS)
Time frame: From the date of enrollment until the date of death from any cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
Time frame: Through study completion, an average of 2 years
Objective Response Rate
Time frame: Up to 1 year after Relmacabtagene Autoleucel infusion
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 21 Jan 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autoleucel (Relmacabtagene Autoleucel) and Sintilimab (PD-1 inhibitor) in people with Large B Cell Diffuse Lymphoma and Mantle Cell Lymphoma (MCL), run by Sun Yat-sen University at 3 sites 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 9 inclusion and 13 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Qingqing Cai, MD. PhD (02087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete response rate (CRR) at 3 months (time frame: Up to 3 months after Relmacabtagene Autoleucel infusion). 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 21 Jan 2026.