Long Term Follow Up Study for Participants of Kite Sponsored Interventional Studies Treated with Gene Modified Cells

No experimental treatments will be administered or tested in the main part of
the long-term follow-up study.
All of Kite*s studies involve long-term follow-up, and previously this was done
within each separate study, The aim of this study is to transition all of the
subjects in follow-up in separate studies into one long-term follow-up study,
which has been designed to be more flexible for subjects (for example you can
choose telephone or email communications if you prefer over site visits).

This study has been transitioned to CTIS with ID 2023-507041-28-00 check the CTIS register for the current data.

The primary objectives of this study are to:
• Evaluate the incidence and severity of late-onset targeted adverse events
(AEs)/serious adverse events (SAEs) suspected to be possibly related to
gene-modified cells, including neurologic disorders, autoimmune disorders,
hematologic disorders, serious infections, and secondary malignancies
• Evaluate mechanism of RCR/RCL and/or insertional mutagenesis for confirmed
events related to the cell therapy product
• Evaluate the growth, development, and sexual maturity of pediatric and
adolescent subjects treated with gene modified cells
The secondary objectives of this study are to:
• Determine the time to next treatment after administration of gene-modified
cell therapy in the completed parent study
• Determine survival status
• Determine cause of death
• Evaluate immune reconstitution
• Evaluate the incidence of replication-competent
retrovirus/replication-competent lentivirus (RCR/RCL)
Exploratory objectives of this study are to:
• Evaluate the levels of genetically-modified cells in blood
• Determine the status of the primary malignant disease
• Evaluate pregnancy outcomes in females of childbearing potential

This is a prospective, long-term follow-up (LTFU) study of subjects who
received an infusion of gene modified cells in a Kite-sponsored interventional
study.
Subjects will be asked to join this study upon completion of the parent
interventional study. Subjects will continue to be monitored for up to 15 years
from the time of the initial infusion of gene-modified cells in the parent
study.
Study data may be obtained from clinical, laboratory, and diagnostic
assessments conducted at the investigative site or from records obtained from
the subject*s referring health care provider. In addition, samples may be
collected from subjects who develop secondary malignancies suspected to be
possibly related to gene-modified cells and/or suspected RCR/RCL infection.

The duration of the study for individual subjects will vary depending on a
subject*s response to treatment, survival, and the time of entry into this LTFU
study from the parent study. For a subject who completes the entire protocol,
the duration of the LTFU study will be up to 15 years from the time of the
initial infusion of gene modified cells in the parent study.

Each subject will proceed through the following study periods:
• Enrollment
• Long-term Follow-up:
* Every 3 months (± 2 weeks) starting at Month 6 through Month 18 after the
initial infusion of gene modified cell therapy
* Month 24 (± 1 month) and then annually (± 3 months or per standard of care)
until Year 15 after the initial infusion of gene modified cell therapy
• Retreatment (if applicable):
* Screening period
* Leukapheresis period (if required)
* Bridging therapy (optional)
* Lymphodepleting chemotherapy period
* Investigational product (IP) retreatment period
* Post-treatment follow-up period

Blood collection
The risks of taking blood include pain at the site of the needle entry, a
bruise at the point where the blood is taken, redness and swelling of the vein
and infection, and a rare risk of fainting.

Tumor tissue biopsy (if applicable)
A tumor tissue biopsy is a procedure that involves removing samples of tumor
surgically, or percutaneously (through the skin) using a hollow *core* needle.
To undergo a biopsy, you will be given medication to numb the area and reduce
the pain. Then a small cut may be made in the skin. The biopsy may cause some
pain and discomfort or bleeding. It is possible, but not likely, that you
could get an infection. In very rare cases, people might have an allergic
reaction to the numbing medicine. The allergic reaction could include
rash/hive, flushing of the face, itching, wheezing, and tightness in the
throat. There may be a small scar from the biopsy.

Bone marrow aspirate and biopsy (if applicable)
A bone marrow aspirate and biopsy is performed using a hollow needle to remove
a small sample of bone marrow. Before the biopsy, a local anaesthetic is used
to numb the area where the needle will be inserted. The procedure may cause
discomfort, pain, bleeding, scarring, or infection at the site of the
aspirate/biopsy. If the aspiration results in a dry tap, a biopsy will be
performed.