search
Back to results

Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y002#

Primary Purpose

Relapsed/Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI346
Sponsored by
Chunrui Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 and above, no gender limitation.
  2. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
  3. Prior treatment of at least 3 lines of treatment, with at least 1 full treatment cycle for each line of treatment (unless the best recorded outcome is progressive disease (PD), according to IMWG criteria); Proteasome inhibitors and immunomodulators must be included.
  4. Documented disease progression during or within 12 months of the most recent anti-myeloma treatment.
  5. Determine the presence of measurable lesions during screening
  6. ECOG score is 0 or 1.
  7. Expected survival time ≥12 weeks.

Exclusion Criteria:

  1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants.
  2. 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.
  3. Prior BCMA targeted therapy.
  4. No unmobilized mononuclear cells can be collected for CAR T cell production.
  5. 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).
  6. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

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)
Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level and the content of soluble BCMA in blood

Full Information

First Posted
February 23, 2022
Last Updated
November 23, 2022
Sponsor
Chunrui Li
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05266768
Brief Title
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y002#
Official Title
An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chunrui Li
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
36 (Anticipated)

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
Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level and the content of soluble BCMA in blood
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunrui Li
Phone
86-13647233185
Email
cunrui5650@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunrui Li
Organizational Affiliation
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hu Bei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ChunRui Li
Phone
+86 13647233185
Email
cunrui5650@126.com

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#CIBI346Y002#

We'll reach out to this number within 24 hrs