Clinical trial NCT05266768: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Innovent Biologics (Suzhou) Co. Ltd.
First posted: 2022-03-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: 21 days post IBI346 administration
measure: Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria
timeFrame: 2 years post IBI346 administration
measure: Presence or absence of replication-competent lentivirus (RCL)
timeFrame: Baseline up to 15 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 3 months post IBI346 administration
measure: Duration of Response (DOR)
timeFrame: 2 years post IBI346 administration
measure: Progression-free Survival (PFS)
timeFrame: 2 years post IBI346 administration
measure: Overall Survival (OS)
timeFrame: 2 years post IBI346 administration
measure: Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)
timeFrame: 2 years post IBI346 administration
measure: Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)
timeFrame: 2 years post IBI346 administration
measure: Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)
timeFrame: 2 years post IBI346 administration
measure: Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)
timeFrame: 2 years post IBI346 administration
measure: Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)
timeFrame: 2 years post IBI346 administration
measure: Pharmacokinetics parameters of IBI346 antibody- clearance (CL)
timeFrame: 2 years post IBI346 administration
measure: Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)
timeFrame: 2 years post IBI346 administration
measure: Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level and the content of soluble BCMA in blood
timeFrame: 2 years post IBI346 administration
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hu Bei
Study officials:
affiliation: Tongji Hospital
name: Chunrui Li
role: PRINCIPAL_INVESTIGATOR
References: