Clinical trial NCT05509855: A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
Official title: A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: T-cell Acute Lymphoblastic Leukemia
T-cell Lymphoblastic Lymphoma
Keywords: T-ALL
T-LBL
Lead sponsor: Wugen, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population will consist of patients who participated in a previous clinical trial where WU-CART-007 was administered.

Brief summary: This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.

Detailed description: This long-term follow-up (LTFU) study is designed to follow patients for up to 15 years after WU-CART-007 infusion to evaluate the persistence of the WU-CART-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. Long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored.

Patients will transition to this LTFU study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. Patients will be contacted every 6 months for the first 5 years following WU-CART-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior WU-CART-007 treatment or until death, whichever occurs first.

Patients will be evaluated either at the treating site or by the patient's primary Health Care Provider (HCP). Patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.

Eligibility criteria: Inclusion Criteria: Patients that received WU-CART-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study.

Exclusion Criteria: Not Applicable

Primary outcomes:
measure: Delayed adverse events (AEs)/serious adverse events (SAEs)
timeFrame: up to 15 years
measure: Persistence of WU-CART-007 cells
timeFrame: Every 6 months for up to 5 years and then yearly for up to 15 years
measure: Tanner Staging
timeFrame: up to 15 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 15 years
measure: Progression-free survival (PFS)
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital LA
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Melbourne
country: Australia
facility: Peter MacCullam Cancer Center
Study officials:
affiliation: Wugen, Inc.
name: Cherry Thomas, MD
role: STUDY_DIRECTOR
References: