An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma

Phase 1

Withdrawn

• Conditions: Relapsed/Refractory Multiple Myeloma
• Interventions: Drug: ICI201

• Registration Number: NCT05980507
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

An open label, single-arm clinical study evaluating the safety and efficacy of ICI201 infusion in relapsed/refractory multiple myeloma

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Study Start: 2023-10-09
• Primary Completion: 2023-10-18
• Study Completion: 2023-10-18
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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. 6. GPRC5D positive expression in bone marrow plasma cells

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. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICI201	ICI201	-

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity (DLT)	Time Frame: 28 days post ICI201 administration	Dose limiting toxicity (DLT)
Incidence and severity of all adverse events related to study drug	Time Frame: 2 years post ICI201 administration	Incidence and severity of all adverse events related to study drug

Trial Locations

Locations (1)

First Affiliated Hospital, Soochow University; 🇨🇳 Suzhou, Jiangsu, China