Follicular Lymphoma (FL)Phase 3NCT07562022
A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 3 study testing SCTB35 injection, Rituximab and Lenalidomide in people with Follicular Lymphoma (FL), run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular lymphoma (FL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Follicular Lymphoma (FL)
- What is being tested?
- SCTB35 injection, Rituximab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2026to Jun 2029
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old
- Histologically confirmed Follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2022 criteria
- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy
- Judged by the investigator, the participant must urgently need to receive systemic treatment, based on meeting at least one GELF criterion
- A measurable or evaluable disease at the time of enrolment
- ECOG PS 0-2
- Adequate organ function and bone marrow function
- Expected survival ≥ 6 months
Who cannot join
- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization
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, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, M.D., 010-88196118, SongYQ_VIP@163.com
About this study
Official title: A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular lymphoma (FL).
- Conditions
- Follicular Lymphoma (FL)
- Being tested
- SCTB35 injection, Rituximab, Lenalidomide
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTB35 injectionDrug
SCTB35 will be subcutaneously administered at a dose as specified
RituximabDrug
Intravenous Infusion
LenalidomideDrug
Oral Capsules
| Study group | Role | What they receive |
|---|---|---|
| SCTB35 and Lenalidomide | Experimental | Not described Receives: Drug: SCTB35 injection; Drug: Lenalidomide |
| Rituximab and Lenalidomide | Active comparator | Not described Receives: Drug: Rituximab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Measured: Up to approximately 3 years
Progression free survival (PFS)
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
Measured: Up to approximately 3 years
Secondary outcomes (10)
Percentage of Participants Achieving Best Overall Response (BOR)
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Measured: Up to approximately 3 years
Percentage of Participants Achieving CR
Percentage of participants who achieve a CR determined per Lugano criteria.
Measured: Up to approximately 3 years
Overall Survival (OS)
Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
Measured: Up to approximately 3 years
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Measured: Up to approximately 3 years
Time to Response (TTR)
Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Measured: Up to approximately 3 years
Event-Free Survival (EFS)
EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first).
Measured: Up to approximately 3 years
Duration of Complete Response (DOCR)
DOCR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
Measured: Up to approximately 3 years
Time to Complete Response (TTCR)
Time to complete response is defined for participants achieving a CR as the time from starting therapy to first a CR.
Measured: Up to approximately 3 years
Blood Concentrations of SCTB35
The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)
Measured: Up to approximately 1 years
Anti-drug Antibodies of SCTB35
Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start9 Jun 2026
- Primary completionMay 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma (FL)Studies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562022
- Sponsor's protocol ID
- SCTB35-A301
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT07562022
- Acronym / sponsor ID
- SCTB35-A301
- Conditions
- Follicular Lymphoma (FL)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 1 May 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.
The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular lymphoma (FL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCTB35 and Lenalidomide | Experimental | Drug: SCTB35 injection, Drug: Lenalidomide |
| Rituximab and Lenalidomide | Active comparator | Drug: Rituximab, Drug: Lenalidomide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-80 years old
- Histologically confirmed Follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2022 criteria
- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy
- Judged by the investigator, the participant must urgently need to receive systemic treatment, based on meeting at least one GELF criterion
- A measurable or evaluable disease at the time of enrolment
Key exclusion criteria (2 listed)
- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization
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 |
|---|---|---|
| SCTB35 injectionSCTB35 will be subcutaneously administered at a dose as specified | Drug | SCTB35 and Lenalidomide |
| RituximabIntravenous Infusion | Drug | Rituximab and Lenalidomide |
| LenalidomideOral Capsules | Drug | Rituximab and Lenalidomide, SCTB35 and Lenalidomide |
Primary outcome
Adverse Events
Time frame: Up to approximately 3 years
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Progression free survival (PFS)
Time frame: Up to approximately 3 years
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
10 secondary outcomes
Percentage of Participants Achieving Best Overall Response (BOR)
Time frame: Up to approximately 3 years
Percentage of Participants Achieving CR
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Time frame: Up to approximately 3 years
Time to Response (TTR)
Time frame: Up to approximately 3 years
Event-Free Survival (EFS)
Time frame: Up to approximately 3 years
Duration of Complete Response (DOCR)
Time frame: Up to approximately 3 years
Time to Complete Response (TTCR)
Time frame: Up to approximately 3 years
Blood Concentrations of SCTB35
Time frame: Up to approximately 1 years
Anti-drug Antibodies of SCTB35
Time frame: Up to approximately 3 years
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 13 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCTB35 injection, Rituximab and Lenalidomide in people with Follicular Lymphoma (FL), run by Sinocelltech Ltd. 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 8 inclusion and 2 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 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. 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 13 Aug 2026.