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

Phase 1

• Conditions: Relapsed/Refractory Multiple Myeloma
• Interventions: Drug: IBI346

• Registration Number: NCT05266768
• Lead Sponsor: Chunrui Li

Brief Summary

An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Status Verified: 2022-03
• Study First Posted: 2022-03-04
• Study Start: 2022-04-28
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-30
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
2. 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).
3. Measurable disease as defined by the protocol
4. ECOG score is 0 or 1.
5. Expected survival time ≥12 weeks.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI346	IBI346	Single arm

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity (DLT)	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	2 years post IBI346 administration
Presence or absence of replication-competent lentivirus (RCL)	Baseline up to 15 years

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)	2 years post IBI346 administration
Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level and the content of soluble BCMA in blood	2 years post IBI346 administration
Duration of Response (DOR)	2 years post IBI346 administration	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)	2 years post IBI346 administration	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.
Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)	2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)	2 years post IBI346 administration
Overall Survival (OS)	2 years post IBI346 administration	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)	2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)	2 years post IBI346 administration
Objective Response Rate (ORR)	3 months post IBI346 administration	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）
Pharmacokinetics parameters of IBI346 antibody- clearance (CL)	2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)	2 years post IBI346 administration

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hu Bei, China