Details

IRB Study Number 22-1024

Status Recruiting

Institute Taussig Cancer Institute

Description

Description

Not listed

Inclusion Criteria

Inclusion Criteria

  1. Treating physician confirms patient is eligible for treatment with cilta-cel CAR-T per United States Prescribing

Information (USPI).

  1. 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

Exclusion Criteria

Not listed