Status:
COMPLETED
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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
- 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
- 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).
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05270928
Start Date
April 27 2022
End Date
May 29 2023
Last Update
July 27 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000