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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05266768
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chunrui Li
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chunrui Li
Principal Investigator Affiliation	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsed/Refractory Multiple Myeloma

Arms & Interventions

Arms

Experimental: IBI346

Single arm

Interventions

Drug: - IBI346

IBI346 Antibody and IBI346 CAR-T cell injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Wuhan, Hu Bei, China

Status

Recruiting

Address

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hu Bei, 430000

Site Contact

ChunRui Li

cunrui5650@126.com

+86 13647233185

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