Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#

Soochow University

Status and phase: Completed; Phase 1

Conditions: Relapsed/Refractory Multiple Myeloma

Treatments: Drug: IBI346

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05270928

CIBI346Y001

Details and patient eligibility

About

An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma

Enrollment: 6 patients

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.

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. No unmobilized mononuclear cells can be collected for CAR T cell production.
4. 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).
5. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

IBI346

Experimental group

Description:

Single arm

Treatment:

Drug: IBI346