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

Relapsed/Refractory Multiple Myeloma Clinical Trial

Official title:

An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266768
• Other study ID #: CIBI346Y002
• Status: Recruiting
• Phase: Phase 1
• Start date: April 28, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2022
• Source: Tongji Hospital
• Contact: Chunrui Li
• Phone: 86-13647233185
• Email: cunrui5650[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

Drug:
• IBI346
IBI346 Antibody and IBI346 CAR-T cell injection

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hu Bei

Sponsors (2)

Lead Sponsor	Collaborator
Chunrui Li	Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)		21 days post IBI346 administration
Primary	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
Primary	Presence or absence of replication-competent lentivirus (RCL)		Baseline up to 15 years
Secondary	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)	3 months post IBI346 administration
Secondary	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).	2 years post IBI346 administration
Secondary	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.	2 years post IBI346 administration
Secondary	Overall Survival (OS)	OS is measured from the date of the initial administration of IBI346 to the date of the subject's death.	2 years post IBI346 administration
Secondary	Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)		2 years post IBI346 administration
Secondary	Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)		2 years post IBI346 administration
Secondary	Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)		2 years post IBI346 administration
Secondary	Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)		2 years post IBI346 administration
Secondary	Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)		2 years post IBI346 administration
Secondary	Pharmacokinetics parameters of IBI346 antibody- clearance (CL)		2 years post IBI346 administration
Secondary	Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)		2 years post IBI346 administration
Secondary	Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level and the content of soluble BCMA in blood		2 years post IBI346 administration