DLBCLPhase 1NCT05039658
Efficacy and Safety of IBI110 Single Agent and in Combination With Sintilimab in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)
A Phase 1 study testing IBI110 plus sintilimab and IBI110 in people with DLBCL, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine whether treatment with IBI110 single agent and in combination with sintilimab demonstrates sufficient efficacy/safety in r/r DLBCL. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- DLBCL
- What is being tested?
- IBI110 plus sintilimab and IBI110
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2021to 2 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Male or female, 18-70 years old (at the time consent is obtained)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed diagnosis of DLBCL in a subject who has been pretreated with at least 2 lines of systematic treatment (regimens containing anthracyclines and anti-CD20 immunotherapy must be included);
- Subjects whose most recent therapy was CAR-T cell therapy were also eligible.
Who cannot join
- Patients previously exposed to any anti-LAG-3 treatment.
- History of ≥Grade 3 CRS, neurotoxicity, or hemophagocytic lymphohistiocytosis) during previous CAR-T cell therapy.
- Impaired cardiac function or clinically significant cardiac disease.
- Active, known or suspected autoimmune disease or a documented history of autoimmune disease within two years prior to screening with a few exceptions as per protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, PhD, MD, 021-64370045, zwl_trial@163.com
About this study
Official title: A Phase Ib, Open Label, Randomized, Multicenter Study of the Efficacy and Safety of IBI110 Single Agent and in Combination With Sintilimab for Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)
The purpose of this study is to determine whether treatment with IBI110 single agent and in combination with sintilimab demonstrates sufficient efficacy/safety in r/r DLBCL.
Read the detailed description
This is a phase Ib, open-label, randomized study to determine the efficacy and safety of treatment with IBI110 single agent and in combination with sintilimab in DLBCL that are relapsed and/or refractory to available standard of care therapies.
Participants in each cohort are randomly assigned to one of the two arms: IBI110 single agent arm and IBI110 in combination with sintilimab arm. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Lugano 2014 Criteria for Malignant Lymphoma (Cheson et al 2014)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.
- Conditions
- DLBCL
- Being tested
- IBI110 plus sintilimab, IBI110
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI110 plus sintilimabDrug
Sintilimab is a NMPA approved high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.
IBI110Drug
BI110 is a high-affinity, ligand-blocking, humanized anti- Lymphocyte Activation Gene-3 (LAG-3) IgG4 antibody that blocks the binding of LAG-3 to MHCII.
| Study group | Role | What they receive |
|---|---|---|
| Single agent treatment arm with IBI110 | Experimental | IBI110 administered at RP2D Receives: Drug: IBI110 |
| Combination treatment arm with IBI10 and sintilimab | Experimental | IBI110 and sintilimab administered at RP2D Receives: Drug: IBI110 plus sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Percentage of subjects achieving complete remission and partial remission in the studied cohort
Measured: Up to 24 months
The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Measured: Up to 24 months
Secondary outcomes (4)
complete response rate
The percentage of subjects that achieved complete response in the studied cohort
Measured: Up to 24 months
DoR
DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the the Lugano 2014 criteria or death regardless of cause.
Measured: Up to 24 months
PFS
PFS is defined as the time from the treatment date to the date of disease progression per Lugano 2014 criteria or death regardless of cause.
Measured: Up to 24 months
OS
OS is defined as the time from treatment to the date of death.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start27 Sep 2021 (estimated)
- Primary completion12 Jul 2022 (estimated)
- Study completion2 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039658
- Sponsor's protocol ID
- CIBI110B201
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 9 Sep 2021
- 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 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open Label, Randomized, Multicenter Study of the Efficacy and Safety of IBI110 Single Agent and in Combination With Sintilimab for Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)
- ClinicalTrials.gov ID
- NCT05039658
- Acronym / sponsor ID
- CIBI110B201
- Conditions
- DLBCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (estimated)
- Primary completion
- 12 Jul 2022 (estimated)
- Study completion
- 2 Dec 2022 (estimated)
- First posted
- 9 Sep 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 determine whether treatment with IBI110 single agent and in combination with sintilimab demonstrates sufficient efficacy/safety in r/r DLBCL.
Detailed description
This is a phase Ib, open-label, randomized study to determine the efficacy and safety of treatment with IBI110 single agent and in combination with sintilimab in DLBCL that are relapsed and/or refractory to available standard of care therapies.
Participants in each cohort are randomly assigned to one of the two arms: IBI110 single agent arm and IBI110 in combination with sintilimab arm. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Lugano 2014 Criteria for Malignant Lymphoma (Cheson et al 2014)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single agent treatment arm with IBI110 | Experimental | Drug: IBI110IBI110 administered at RP2D |
| Combination treatment arm with IBI10 and sintilimab | Experimental | Drug: IBI110 plus sintilimabIBI110 and sintilimab administered at RP2D |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Male or female, 18-70 years old (at the time consent is obtained)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed diagnosis of DLBCL in a subject who has been pretreated with at least 2 lines of systematic treatment (regimens containing anthracyclines and anti-CD20 immunotherapy must be included);
- Subjects whose most recent therapy was CAR-T cell therapy were also eligible.
Key exclusion criteria (4 listed)
- Patients previously exposed to any anti-LAG-3 treatment.
- History of ≥Grade 3 CRS, neurotoxicity, or hemophagocytic lymphohistiocytosis) during previous CAR-T cell therapy.
- Impaired cardiac function or clinically significant cardiac disease.
- Active, known or suspected autoimmune disease or a documented history of autoimmune disease within two years prior to screening with a few exceptions as per protocol.
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 |
|---|---|---|
| IBI110 plus sintilimabSintilimab is a NMPA approved high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1. | Drug | Combination treatment arm with IBI10 and sintilimab |
| IBI110BI110 is a high-affinity, ligand-blocking, humanized anti- Lymphocyte Activation Gene-3 (LAG-3) IgG4 antibody that blocks the binding of LAG-3 to MHCII. | Drug | Single agent treatment arm with IBI110 |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 24 months
Percentage of subjects achieving complete remission and partial remission in the studied cohort
The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)
Time frame: Up to 24 months
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
4 secondary outcomes
complete response rate
Time frame: Up to 24 months
DoR
Time frame: Up to 24 months
PFS
Time frame: Up to 24 months
OS
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- 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 study testing IBI110 plus sintilimab and IBI110 in people with DLBCL, run by Innovent Biologics (Suzhou) Co. 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 5 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: status not confirmed, as of the sponsor's last update on 9 Sep 2021. 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 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?
Contact yong wang (0512-69566088, yong.wang@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 24 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 9 Sep 2021.