Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05509855




Registration number
NCT05509855
Ethics application status
Date submitted
20/07/2022
Date registered
22/08/2022
Date last updated
7/09/2023

Titles & IDs
Public title
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
Scientific title
A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)
Secondary ID [1] 0 0
WUC007-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
T-cell Acute Lymphoblastic Leukemia 0 0
T-cell Lymphoblastic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Genetic: WU-CART-007

Patients treated with WU-CART-007 - Patients who received previous treatment with WU-CART-007


Other interventions: Genetic: WU-CART-007
No study drug is administered in this study. Patients who have received WU-CART-007 will be enrolled in this study for Long Term Safety and Efficacy
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Delayed adverse events (AEs)/serious adverse events (SAEs)
Timepoint [1] 0 0
up to 15 years
Primary outcome [2] 0 0
Persistence of WU-CART-007 cells
Timepoint [2] 0 0
Every 6 months for up to 5 years and then yearly for up to 15 years
Primary outcome [3] 0 0
Tanner Staging
Timepoint [3] 0 0
up to 15 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
up to 15 years
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
up to 15 years

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not Applicable

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2037
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCullam Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wugen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05509855
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jan Davidson-Moncada, MD, PhD
Address 0 0
Wugen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05509855