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

• Status: Not yet recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University

Criteria

Inclusion Criteria:

1. Age 18 and above, no gender limitation.

2. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.

3. Prior treatment of at least 3 lines of treatment, with at least 1 full treatment cycle for each line of treatment (unless the best recorded outcome is progressive disease (PD), according to IMWG criteria); Proteasome inhibitors and immunomodulators must be included.

4. Documented disease progression during or within 12 months of the most recent anti-myeloma treatment.

5. Determine the presence of measurable lesions during screening

6. ECOG score is 0 or 1.

7. Expected survival time ≥12 weeks.

Exclusion Criteria:

1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants.

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. Prior BCMA targeted therapy.

4. No unmobilized mononuclear cells can be collected for CAR T cell production.

5. 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).

6. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).