Relapsed/Refractory Follicular LymphomaPhase 3NCT07355283
IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
A Phase 3 study testing IMM0306 2.0 mg/kg and Lenalidomide 20 mg in people with Relapsed/Refractory Follicular Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
Trial summary
This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Follicular Lymphoma
- What is being tested?
- IMM0306 2.0 mg/kg and Lenalidomide 20 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Oct 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one measurable lesion (as per Lugano 2014 criteria).
- Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.
- Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.
- Adequate hepatic, hematologic, and renal function.
- Expected survival at least 6 months.
Who cannot join
- Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
- History of central nervous system (CNS) metastases or active CNS involvement.
- History of other malignancy within the past 5 years.
- Severe organic cardiovascular or cerebrovascular diseases.
- History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.
- Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
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- Human immunodeficiency virus (HIV) infection.
- Echocardiography examination indicating left ventricular ejection fraction (LVEF) < 55%.
- Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Being tested
- IMM0306 2.0 mg/kg, Placebo, Lenalidomide 20 mg
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM0306 2.0 mg/kgDrug
Also called Amulirafusp Alfa
IV infusion;
PlaceboDrug
IV infusion;
Lenalidomide 20 mgDrug
orally
| Study group | Role | What they receive |
|---|---|---|
| IMM0306 in combination with lenalidomide | Experimental | One treatment cycle consists of 4 weeks (28 days). IMM0306 (Amulirafusp Alfa) will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle. Receives: Drug: IMM0306 2.0 mg/kg; Drug: Lenalidomide 20 mg |
| Placebo in combination with lenalidomide | Placebo comparator | One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle. Receives: Drug: Placebo; Drug: Lenalidomide 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate(CRR) as Assessed by Investigator
CRR is defined as the percentage of participants who achieve a CR(Complete Response) determined per Lugano 2014 criteria (2014 Lugano Revised Response Criteria for Malignant Lymphoma).
Measured: approximately 48 months
Progression-Free Survival (PFS) as Assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: approximately 48 months
Secondary outcomes (7)
Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC)
CRR is defined as the percentage of participants who achieve a CR determined per Lugano 2014 criteria.
Measured: approximately 48 months
Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: approximately 48 months
Objective Response Rate (ORR)
ORR is defined as the proportion of the analysis population achieving CR, PR(Partial Response).
Measured: approximately 48 months
Duration of Response (DOR)
DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first.
Measured: approximately 48 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: approximately 60 months
Time to Next Anti-Lymphoma Treatment(TTNT)
TTNT is defined as the number of days from randomization to the date of next anti-lymphoma treatment.
Measured: approximately 48 months
Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Follicular LymphomaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355283
- Sponsor's protocol ID
- IMM0306-004
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT07355283
- Acronym / sponsor ID
- IMM0306-004
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 21 Jan 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 study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMM0306 in combination with lenalidomide | Experimental | Drug: IMM0306 2.0 mg/kg, Drug: Lenalidomide 20 mgOne treatment cycle consists of 4 weeks (28 days). IMM0306 (Amulirafusp Alfa) will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle. |
| Placebo in combination with lenalidomide | Placebo comparator | Drug: Placebo, Drug: Lenalidomide 20 mgOne treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one measurable lesion (as per Lugano 2014 criteria).
- Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.
- Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.
- Adequate hepatic, hematologic, and renal function.
Key exclusion criteria (9 listed)
- Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
- History of central nervous system (CNS) metastases or active CNS involvement.
- History of other malignancy within the past 5 years.
- Severe organic cardiovascular or cerebrovascular diseases.
- History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.
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 |
|---|---|---|
| IMM0306 2.0 mg/kgAlso: Amulirafusp AlfaIV infusion; | Drug | IMM0306 in combination with lenalidomide |
| PlaceboIV infusion; | Drug | Placebo in combination with lenalidomide |
| Lenalidomide 20 mgorally | Drug | IMM0306 in combination with lenalidomide, Placebo in combination with lenalidomide |
Primary outcome
Complete remission rate(CRR) as Assessed by Investigator
Time frame: approximately 48 months
CRR is defined as the percentage of participants who achieve a CR(Complete Response) determined per Lugano 2014 criteria (2014 Lugano Revised Response Criteria for Malignant Lymphoma).
Progression-Free Survival (PFS) as Assessed by Investigator
Time frame: approximately 48 months
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
7 secondary outcomes
Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC)
Time frame: approximately 48 months
Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC)
Time frame: approximately 48 months
Objective Response Rate (ORR)
Time frame: approximately 48 months
Duration of Response (DOR)
Time frame: approximately 48 months
Overall Survival (OS)
Time frame: approximately 60 months
Time to Next Anti-Lymphoma Treatment(TTNT)
Time frame: approximately 48 months
Adverse Event (AE)
Time frame: approximately 48 months
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 27 Jan 2026.
- Individual participant dataSharing planned: No
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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 IMM0306 2.0 mg/kg and Lenalidomide 20 mg in people with Relapsed/Refractory Follicular Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 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 6 inclusion and 9 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 27 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 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. Some participants in this study may receive a placebo. 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?
Contact Yuqin Song, Professor (010-88196118, SongYQ_VIP@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate(CRR) as Assessed by Investigator (time frame: approximately 48 months). 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 27 Jan 2026.