Relapsed/Refractory Multiple MyelomaPhase 1NCT05270928
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#
A Phase 1 study testing IBI346 in people with Relapsed/Refractory Multiple Myeloma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- IBI346
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2022to 29 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
- Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
- Measurable disease as defined by the protocol
- ECOG score is 0 or 1.
- Expected survival time ≥12 weeks.
Who cannot join
- Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
- Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
- No unmobilized mononuclear cells can be collected for CAR T cell production.
- Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day).
- Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myelom
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- IBI346
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI346Drug
IBI346 Antibody and IBI346 CAR-T cell injection
| Study group | Role | What they receive |
|---|---|---|
| IBI346 | Experimental | Single arm Receives: Drug: IBI346 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Measured: 21 days post IBI346 administration
Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria
Measured: 2 years post IBI346 administration
Presence or absence of replication-competent lentivirus (RCL)
Measured: Baseline up to 15 years
Secondary outcomes (13)
Objective Response Rate (ORR)
Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working Group response criteria（2016）
Measured: 3 months post IBI346 administration
Duration of Response (DOR)
DOR will be calculated among responders (with a PR or better response) from the date of initial response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2016).
Measured: 2 years post IBI346 administration
Progression-free Survival (PFS)
PFS defined as time from date of initial administration of IBI346 to date of first disease progression according to IMWG criteria (2016), or death due to any cause, whichever occurs first.
Measured: 2 years post IBI346 administration
Overall Survival (OS)
OS is measured from the date of the initial administration of IBI346 to the date of the subject's death.
Measured: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)
Measured: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)
Measured: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)
Measured: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)
Measured: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)
Measured: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- clearance (CL)
Measured: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)
Measured: 2 years post IBI346 administration
Positive rate of human anti-P329G CAR antibody
Measured: 2 years post IBI346 administration
Positive rate of anti-drug antibody (ADA) of P329G BCMA antibody
Measured: 2 years post IBI346 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start27 Apr 2022
- Primary completion21 Dec 2022
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270928
- Sponsor's protocol ID
- CIBI346Y001
- Status last verified
- May 2023
- First submitted
- 27 Feb 2022
- Last updated
- 27 Jul 2023
- 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 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myelom
- ClinicalTrials.gov ID
- NCT05270928
- Acronym / sponsor ID
- CIBI346Y001
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 8 Mar 2022 (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.
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI346 | Experimental | Drug: IBI346Single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
- Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
- Measurable disease as defined by the protocol
- ECOG score is 0 or 1.
- Expected survival time ≥12 weeks.
Key exclusion criteria (5 listed)
- Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
- Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
- No unmobilized mononuclear cells can be collected for CAR T cell production.
- Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day).
- Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).
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 |
|---|---|---|
| IBI346IBI346 Antibody and IBI346 CAR-T cell injection | Drug | IBI346 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 21 days post IBI346 administration
Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria
Time frame: 2 years post IBI346 administration
Presence or absence of replication-competent lentivirus (RCL)
Time frame: Baseline up to 15 years
13 secondary outcomes
Objective Response Rate (ORR)
Time frame: 3 months post IBI346 administration
Duration of Response (DOR)
Time frame: 2 years post IBI346 administration
Progression-free Survival (PFS)
Time frame: 2 years post IBI346 administration
Overall Survival (OS)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- clearance (CL)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)
Time frame: 2 years post IBI346 administration
Positive rate of human anti-P329G CAR antibody
Time frame: 2 years post IBI346 administration
Positive rate of anti-drug antibody (ADA) of P329G BCMA antibody
Time frame: 2 years post IBI346 administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 IBI346 in people with Relapsed/Refractory Multiple Myeloma, run by The First Affiliated Hospital of Soochow University 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: finished, as of the sponsor's last update on 27 Jul 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose limiting toxicity (DLT) (time frame: 21 days post IBI346 administration). The study lists 3 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 Jul 2023.