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

Soochow University

Status and phase

Withdrawn

Phase 1

Conditions

Relapsed/Refractory Multiple Myeloma

Treatments

Drug: ICI201

Study type

Interventional

Funder types

Other

Identifiers

CICI201Y001

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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