Status:
WITHDRAWN
An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
The First Affiliated Hospital of Soochow University
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 ICI201 infusion in relapsed/refractory multiple myeloma
Eligibility Criteria
Inclusion
- 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. 6. GPRC5D positive expression in bone marrow plasma cells
Exclusion
- 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. 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). 4. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg). 5. Patients who have recieved GPRC5D-targeted therapy
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05980507
Start Date
October 9 2023
End Date
October 18 2023
Last Update
December 22 2023
Active Locations (1)
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1
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000