B-cell Non-Hodgkin's LymphomaPhase 1NCT04746131
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
A Phase 1 study testing IMM0306 in people with B-cell Non-Hodgkin's Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- IMM0306
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 11 Apr 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old
- Diagnosed with B-NHL
- Relapsed after or be refractory to at least 2 line of standard therapy
Who cannot join
- Active central nervous system (CNS) metastases
- Positive Direct Antiglobulin Test (DAT)
- Active autoimmune disorder
- Skin disorders that do not requires hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Being tested
- IMM0306
- Keywords
- IMM0306
- Medical subject headings
- Lymphoma, B-Cell
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 | Experimental | IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks. Receives: Drug: IMM0306 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)
DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.
Measured: End of Study (52 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start15 Jan 2021
- Primary completion11 Apr 2024 (estimated)
- Study completion11 Apr 2024 (estimated)
Why it stopped: Due to the product development strategy change, without any safety concerns, we (the sponsor of the trial) have decided to request to place the IND (#151570) on inactive status.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Cheng Huang, MD, Study director, VP，Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746131
- Sponsor's protocol ID
- IMM0306
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT04746131
- Acronym / sponsor ID
- IMM0306
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Keywords
- IMM0306
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to the product development strategy change, without any safety concerns, we (the sponsor of the trial) have decided to request to place the IND (#151570) on inactive status.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Collaborators
- Worldwide Clinical Trials
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 11 Apr 2024 (estimated)
- Study completion
- 11 Apr 2024 (estimated)
- First posted
- 9 Feb 2021 (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 assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (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 | Experimental | Drug: IMM0306IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years old
- Diagnosed with B-NHL
- Relapsed after or be refractory to at least 2 line of standard therapy
Key exclusion criteria (4 listed)
- Active central nervous system (CNS) metastases
- Positive Direct Antiglobulin Test (DAT)
- Active autoimmune disorder
- Skin disorders that do not requires hormone replacement therapy
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 |
Primary outcome
Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)
Time frame: End of Study (52 Weeks)
DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
Related trials for B-cell Non-Hodgkin's Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
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.
Cheng Huang, MD study director
VP，Clinical Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMM0306 in people with B-cell Non-Hodgkin's Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in United States.
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 3 inclusion and 4 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: paused, as of the sponsor's last update on 26 Sep 2022. 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 United States. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity) (time frame: End of Study (52 Weeks)). 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 26 Sep 2022.