Overview

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

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:
Huazhong University of Science and Technology
Collaborator:
Innovent Biologics (Suzhou) Co. Ltd.
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).