CD20-positive B-cell Non-Hodgkin's LymphomaPhase 1/2NCT05805943
Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
A Phase 1/2 study testing IMM0306 in people with CD20-positive B-cell Non-Hodgkin's Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
Trial summary
This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD20-positive B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- IMM0306
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2020to 25 May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
- At least one measurable or assessable tumor lesion.
- Adequate organ and hematologic function.
- Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
- All adverse events from prior treatment must be CTCAE v5.0 grade <= 1
Who cannot join
- Active central nervous system (CNS) lymphoma.
- Systemic steroid therapy (dose equivalent to > 10 mg prednisone / day).
- History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade >=3).
- Have evidence of severe uncontrollable active infection.
- Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yuankai Shi, 010-87788268
About this study
Official title: Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).
- Being tested
- IMM0306
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM0306Drug
IMM0306 is an bi-specific antibody
| Study group | Role | What they receive |
|---|---|---|
| IMM0306 Monotherapy | Experimental | Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level.
Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part. Receives: Drug: IMM0306 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Measured: Evaluated for DLTs during the first 28-day cycle
Complete response rate
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start2 Mar 2020
- Primary completion25 May 2025 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CD20-positive B-cell Non-Hodgkin's 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 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
- NCT05805943
- Sponsor's protocol ID
- IMM0306-I
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang J, Song Y, Zhou K, Li Z, Zhang M, Jing H, Wang Z, Yu L, Meng W, Lu Q, Tian W, Shi Y. Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPalpha, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study. J Hematol Oncol. 2024 Dec 18;17(1):123. doi: 10.1186/s13045-024-01646-2.
PubMed 39696680
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05805943
- Acronym / sponsor ID
- IMM0306-I
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 10 Apr 2023 (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 Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMM0306 Monotherapy | Experimental | Drug: IMM0306Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level. Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
- At least one measurable or assessable tumor lesion.
- Adequate organ and hematologic function.
- Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
- All adverse events from prior treatment must be CTCAE v5.0 grade <= 1
Key exclusion criteria (5 listed)
- Active central nervous system (CNS) lymphoma.
- Systemic steroid therapy (dose equivalent to > 10 mg prednisone / day).
- History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade >=3).
- Have evidence of severe uncontrollable active infection.
- Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.
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 |
|---|---|---|
| IMM0306IMM0306 is an bi-specific antibody | Drug | IMM0306 Monotherapy |
Primary outcome
Dose-limiting toxicity
Time frame: Evaluated for DLTs during the first 28-day cycle
Complete response rate
Time frame: up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Derived from this study: PubMed 39696680Yang J, Song Y, Zhou K, Li Z, Zhang M, Jing H, Wang Z, Yu L, Meng W, Lu Q, Tian W, Shi Y. Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPalpha, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study. J Hematol Oncol. 2024 Dec 18;17(1):123. doi: 10.1186/s13045-024-01646-2.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMM0306 in people with CD20-positive B-cell Non-Hodgkin's 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Dose-limiting toxicity (time frame: Evaluated for DLTs during the first 28-day cycle). 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?
On the ClinicalTrials.gov record for NCT05805943, which also lists 1 linked publication.
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 10 Apr 2023.