For Healthcare Professionals

Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y002#

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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).
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Relapsed/Refractory Multiple Myeloma

Age (in years)

18+

Phase

Phase 1

Participants needed

36

Est. Completion Date

Feb 28, 2024

Treatment type

Interventional


Sponsor

Tongji Hospital

ClinicalTrials.gov identifier

NCT05266768

Study number

CIBI346Y002

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