This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for Phase 1 studies that evaluate the safety and efficacy of CAR T cells: NCT05660369 (DF/HCC# 22-175) and NCT06026319 (DF/HCC# 23-474).

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

Long Term Adverse Effects

CAR-T

Duty to Follow Up

Adult

Progression-Free Survival

Disease-Free Survival

Overall Survival

This is a long-term safety and efficacy follow-up study for subjects who have been treated with CAR T cells in corresponding Phase I main studies that evaluated the safety and efficacy of CAR T cells in subjects.

No investigational treatment will be administered in this study.

The FDA (2020) recommends long-term follow up for subjects treated with gene therapy drug products to monitor for delayed adverse events (AEs), as well as durability of clinical response.

Therefore, after monitoring of subjects in the main studies has been completed (24 months after CAR T cells infusion, or <24 months after CAR T cells infusion if subject terminated early due to disease progression or due to discontinuing corresponding main study for any reason), subjects will be asked to participate in a long-term follow-up study (LTFU).

Subjects will be followed for up to 15 years following their last CAR T cells infusion in the corresponding main study.

Disease assessments

Tumor Biopsy

Blood test

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

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.

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

NCI Common Terminology Criteria for Adverse Events (CTCAE)

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).

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

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.

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

Sponsor Investigator

* Eligibility to participate on this study if enrolled on a DF/HCC IRB corresponding main study and received infusion of CAR T cells
* The research study procedures include evaluations and follow up visits: Timepoints of each evaluation and follow up visit- per protocol
* Medical History/Physical Exam
* Blood Test
* Assessment of Disease: CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans.
* Tumor biopsy.
* Data Collection
* Biobanking

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

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?