Long-term Follow-up of Subjects Treated With CAR T Cells

DIAGNOSTIC_TEST

Disease assessments

CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol

PROCEDURE

Tumor Biopsy

Tumor Biopsy per protocol

DIAGNOSTIC_TEST

Blood test

Blood Test per protocol

Overall Survival

Time frame: 1 month

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Overall Survival

Time frame: 6 months

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Overall Survival

Time frame: 12 months

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Overall Survival

Time frame: 24 months

defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

Progresison Free Survival

Time frame: 1 month

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

Progresison Free Survival

Time frame: 6 months

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

Progresison Free Survival

Time frame: 12 months

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

Progresison Free Survival

Time frame: 24 months

PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

New incidence or exacerbation of a pre-existing neurologic disorder or prior rheumatologic or other autoimmune disorder

Time frame: Up to 15 Years

An annual physical exam will be conducted for surveillance of manifestations indicative of oncoretroviral diseases.

New incidence of a hematologic disorder

Time frame: up to 15 years

An annual physical exam will be conducted for surveillance of manifestations indicative of oncoretroviral diseases.

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v 5.0

Time frame: up to 15 years

NCI Common Terminology Criteria for Adverse Events (CTCAE)

Vector-derived RCL

Time frame: baseline and in 3 months, 6 months, and annually up to 15 years

Archiving of samples for potential detection of vector-derived RCL. RCL testing will be monitored at the central RCL lab (Indiana University) by a suitable qPCR assay for detection of the lentiviral vector (VSV-g DNA).

Assessment of CAR T cells persistence by VCN in peripheral blood

Time frame: baseline and in 3 months, 6 months, every 6 months up to 5 years, and annually up to 15 years

VCN will be performed in DNA from whole blood to monitor for persistence of vector sequence

Progression-free Survival

Time frame: From post-CAR T cells infusion date until date of first documented disease progression or date of death from any cause, assessed up to 15 years post treatment

The number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

Overall Survival

Time frame: From post-CAR T cells infusion date until documented date of death from any cause, assessed post treatment every 6 months through 5 years and then annually up to 15 years

The time from post-CAR T cells infusion to the date of death.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.