Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
Any
Inclusion Criteria:
1. Subject and/or LAR must understand and voluntarily sign an informed consent form
prior to any study-related assessments/procedures being conducted.
2. Subject was prescribed lisocabtagene maraleucel (liso-cel) for a diagnosis that is
approved per local prescribing information, per treating physician assessment.
3. Subject is ≥ 18 years of age at the time of signing the informed consent form.
4. Subject had a subject-specific batch of liso-cel manufactured intended for
commercial treatment; however, the final manufactured product did not meet the local
commercial release criteria.
5. Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible
or clinically inappropriate per assessment of the treating physician in discussion
with the subject.
6. Subject is clinically stable, has recovered from any prior toxicities which places
the subject at clinical risk prior to receiving LD chemotherapy, and has adequate
bone marrow function to receive LD chemotherapy. The treating physician is advised
to contact the Medical Monitor in the event there is any concern regarding
administration of LD chemotherapy.
7. Females of childbearing potential must:
1. Have a negative pregnancy test as verified by the treating physician within 7
days prior to the first dose of lymphodepleting chemotherapy following
institutional testing methodology practices. This applies even if the subject
practices true abstinence from heterosexual contact.
2. Either commit to true abstinence from heterosexual contact or agree to use, and
be able to comply with, effective contraception without interruption.
Contraception methods must include 1 highly effective method from screening
until at least 12 months after the nonconforming liso-cel administration.
3. Agree to abstain from breastfeeding during study participation and for at least
12 months following nonconforming liso-cel administration.
4. There are insufficient exposure data to provide any recommendation concerning
the duration of contraception and the abstaining from breastfeeding following
treatment with liso-cel. Any decision regarding contraception and breastfeeding
after infusion should be discussed with the treating physician.
8. Male subjects must:
1. Practice true abstinence or agree to use a condom during sexual contact with a
pregnant female or a female of childbearing potential for at least 12 months
after nonconforming liso-cel administration even if the subject has undergone a
successful vasectomy.
2. There are insufficient exposure data to provide any recommendation concerning
the duration of contraception following treatment with liso-cel. Any decision
regarding contraception after infusion should be discussed with the treating
physician
9. Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells
for usage in other individuals for at least 1 year following nonconforming liso-cel
administration.
Exclusion Criteria:
1. Subject has a hypersensitivity to the active substance or to any of the excipients.
2. Subject should not experience a significant worsening in clinical status that would,
in the opinion of the treating physician, either increase the risk of adverse events
associated with lymphodepleting chemotherapy, or exclude them from treatment with
nonconforming liso-cel.
3. Subject has any significant medical condition, laboratory abnormality, or
psychiatric illness, sociologic or geographic condition that would prevent the
subject from participating in the Expanded Access Protocol complying with protocol
requirements in the Investigator's judgement.
4. Subject has any condition and/or laboratory abnormality that places the subject at
unacceptable risk if he/she were to participate in the Expanded Access Protocol
based on the Investigator's judgement
5. Pregnant or nursing women or has intention of becoming pregnant during the study.
6. Subjects with primary central nervous system (CNS) lymphoma (note: subjects with
secondary CNS involvement are allowed on study).
7. Subject has uncontrolled hepatitis B, hepatitis C, or human immunodeficiency virus
(HIV) infection at the time of pretreatment evaluation
8. Subject has uncontrolled systemic fungal, bacterial, viral or other infection
despite appropriate antibiotics or other treatment at the time of nonconforming
liso-cel administration.
9. Subject has active acute or chronic graft-versus-host disease (ie, GVHD)
10. Subject should not be actively receiving anticancer treatment that would, in the
opinion of the treating physician, either increase the risk of AEs associated with
LD chemotherapy or CAR T therapy or interfere with site routine care treatment plan
associated with CAR T therapy. The treating physician is advised to consult with the
Medical Monitor for case discussion if needed.