IRB Study Number 22-1024
Status Recruiting
Institute Taussig Cancer Institute
Description
Not listed
Inclusion Criteria
- Treating physician confirms patient is eligible for treatment with cilta-cel CAR-T per United States Prescribing
Information (USPI).
- Treating physicians renders a favorable benefit/risk assessment that clinically justifies proceeding with cilta-cel
OOS as the best treatment option for the patient.
To enable treating physicians to conduct their individual benefit/risk assessment, Janssen will provide them
information regarding the patient manufactured investigational product, including risk assessment of the potential
impact of the OOS on product safety or efficacy.
Treating physician will conduct an individual risk/benefit assessment after considering: risk assessment of the
potential impact of the OOS on product safety or efficacy provided by Janssen, the patient’s clinical status, their
access to alternative treatment options within a reasonable timeframe and the potential consequences/immediate risks
of not receiving the OOS Product.
Janssen will notify and or obtain health authority approval for release of investigational product.
Exclusion Criteria
Not listed
