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New hope for lymphoma patients: experimental drug combo enters final trial phase

NCT ID NCT07355283

Disease control Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether adding the experimental drug IMM0306 to standard lenalidomide can improve outcomes for people with follicular lymphoma that has returned or stopped responding to treatment. About 198 participants will be randomly assigned to receive either IMM0306 or a placebo, both with lenalidomide. The study measures how many achieve complete remission and how long they live without the disease worsening.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMM0306 (Amulirafusp alfa) combined with lenalidomide
What this could lead to
If successful, this combination could offer a new treatment option that helps more people with follicular lymphoma achieve complete remission and delay disease progression.
What could go wrong
This is still an experimental treatment. Even in Phase 3, it may not prove better than existing options, and side effects from the drug combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 198 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 2. At least one measurable lesion (as per Lugano 2014 criteria). 3. Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a. 4. Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody. 5. Adequate hepatic, hematologic, and renal function. 6. Expected survival at least 6 months. Exclusion Criteria: 1. Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation. 2. History of central nervous system (CNS) metastases or active CNS involvement. 3. History of other malignancy within the past 5 years. 4. Severe organic cardiovascular or cerebrovascular diseases. 5. History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies. 6. Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein. 7. Human immunodeficiency virus (HIV) infection. 8. Echocardiography examination indicating left ventricular ejection fraction (LVEF) \< 55%. 9. Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory follicular lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.