Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y002#
About the study
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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).
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Relapsed/Refractory Multiple Myeloma
Age (in years)
18+
Phase
Phase 1
Participants needed
36
Est. Completion Date
Feb 28, 2024
Treatment type
Interventional
Sponsor
Tongji Hospital
ClinicalTrials.gov identifier
NCT05266768
Study number
CIBI346Y002
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