Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#
Primary Purpose
Relapsed/Refractory Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI346
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- The First Affiliated Hospital of Soochow University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBI346
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Dose limiting toxicity (DLT)
Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria
Presence or absence of replication-competent lentivirus (RCL)
Secondary Outcome Measures
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)
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).
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.
Overall Survival (OS)
OS is measured from the date of the initial administration of IBI346 to the date of the subject's death.
Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)
Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)
Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)
Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)
Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics parameters of IBI346 antibody- clearance (CL)
Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)
Positive rate of human anti-P329G CAR antibody
Positive rate of anti-drug antibody (ADA) of P329G BCMA antibody
Full Information
NCT ID
NCT05270928
First Posted
February 27, 2022
Last Updated
July 25, 2023
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05270928
Brief Title
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#
Official Title
An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myelom
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
May 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBI346
Arm Type
Experimental
Arm Description
Single arm
Intervention Type
Drug
Intervention Name(s)
IBI346
Intervention Description
IBI346 Antibody and IBI346 CAR-T cell injection
Primary Outcome Measure Information:
Title
Dose limiting toxicity (DLT)
Time Frame
21 days post IBI346 administration
Title
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
Title
Presence or absence of replication-competent lentivirus (RCL)
Time Frame
Baseline up to 15 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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)
Time Frame
3 months post IBI346 administration
Title
Duration of Response (DOR)
Description
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).
Time Frame
2 years post IBI346 administration
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
2 years post IBI346 administration
Title
Overall Survival (OS)
Description
OS is measured from the date of the initial administration of IBI346 to the date of the subject's death.
Time Frame
2 years post IBI346 administration
Title
Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)
Time Frame
2 years post IBI346 administration
Title
Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)
Time Frame
2 years post IBI346 administration
Title
Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)
Time Frame
2 years post IBI346 administration
Title
Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)
Time Frame
2 years post IBI346 administration
Title
Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)
Time Frame
2 years post IBI346 administration
Title
Pharmacokinetics parameters of IBI346 antibody- clearance (CL)
Time Frame
2 years post IBI346 administration
Title
Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)
Time Frame
2 years post IBI346 administration
Title
Positive rate of human anti-P329G CAR antibody
Time Frame
2 years post IBI346 administration
Title
Positive rate of anti-drug antibody (ADA) of P329G BCMA antibody
Time Frame
2 years post IBI346 administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#
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