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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

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:

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Time Frame

3 months post IBI346 administration

Title

Duration of Response (DOR)

Description

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

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

Learn more about this trial

Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#

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