Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release

Sponsor:

Juno Therapeutics

Sponsor Study ID:

JCAR017-EAP-001

CTO #:

103335

NCT Number:

NCT04400591

Phase:

N/A

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Non-Hodgkin's Lymphoma

Study Objectives:

This is an expanded access protocol that will be conducted at sites qualified and approved to treat patients with lisocabtagene maraleucel. Sometimes when lisocabtagene maraleucel is manufactured the drug does not pass all the testing results to be called lisocabtagene maraleucel. When this happens the drug is called nonconforming lisocabtagene maraleucel. The expanded access protocol will be used to allow patients to receive nonconforming lisocabtagene maraleucel only if the potential benefit is better than the potential risk. This expanded access protocol is restricted to those patients who were prescribed lisocabtagene maraleucel as part of their routine care.

eConsent:

Not available

Study Documents:

Open Study Documents
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