Primary Objective:- Long-term safetySecondary Objective:- Survival- Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression- Chimeric antigen receptor (CAR) transgene persistence- Replication competent…
ID
Source
Brief title
Condition
- Other condition
- Leukaemias
Synonym
Health condition
Plasma Cell Neoplasm, Lymphomas non-Hodgkin's B-cell, Lymphomas non-Hodgkin's T-cell and Leukaemias
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Incidence of serious adverse events related to AUTO CAR T cell therapy.
- New malignancies.
- Other designated adverse events of special interest to AUTO CAR T cell
therapy
Secondary outcome
- Overall survival for up to 15 years after the first AUTO CAR T cell therapy
infusion.
- Duration of response, progression free survival.
- Proportion of patients with detectable vector copy number in peripheral
blood, up to 15 years after the first AUTO CAR T cell therapy infusion.
- Confirm / monitor for absence of detectable RCR, up to 15 years after the
first AUTO CAR T cell therapy infusion.
- In case of new malignancy: Insertion site analysis to determine insertional
mutagenesis as potential cause/contributor in case of new malignancy.
Background summary
Patients exposed to an investigational gene therapy product (e.g. AUTO CAR T
cell therapy) on a treatment study, may be subject to long-term risks and
therefore these patients must be followed up long-term for any delayed Serious
Adverse Events (SAEs) related to treatment with gene therapy products.
The purpose of this study is to monitor all patients exposed to an existing and
authorised AUTO CAR T cell therapy, as well as the Sponsor*s future autologous
T cell products using the same Moloney Murine Leukaemia based retroviral
vector, for up to 15 years following their first AUTO CAR T cell therapy
infusion to assess the risk of delayed SAEs, adverse events of special interest
(AESIs), monitor for emergence of replication competent retrovirus (RCR), and
assess long-term efficacy, including CAR transgene persistence.
Monitoring of such long-term effects of AUTO CAR T cell therapy will help to
further define the risk-benefit profile of these new CAR T cell therapies.
Study objective
Primary Objective:
- Long-term safety
Secondary Objective:
- Survival
- Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to
disease progression
- Chimeric antigen receptor (CAR) transgene persistence
- Replication competent retrovirus (RCR) emergence
- Insertional mutagenesis
Study design
Patients will be enrolled following completion or early discontinuation from an
AUTO CAR T cell therapy treatment study and will be followed for up to 15 years
(or death, whichever happens first) after the first AUTO CAR T cell therapy
infusion. Patients will be monitored for safety, as described in the primary
outcome measures, every 3 months for the year following the first AUTO CAR T
cell therapy infusion, then every 6 months for the next 4 years and then
annually for the following 10 years.
Study burden and risks
Possible adverse effects/discomforts related to blood samples collection
throughout the study.
Forest House, Wood Lane (off Depot Road) 58
London W12 7RZ
GB
Forest House, Wood Lane (off Depot Road) 58
London W12 7RZ
GB
Listed location countries
Age
Inclusion criteria
•Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
•Patients must have provided informed consent for long-term follow-up study prior to participation.
•Patients must be able to comply with the study requirements.
Exclusion criteria
- There are no specific exclusion criteria for this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | CANC 36926 |
| EudraCT | EUCTR2016-004867-38-NL |
| CCMO | NL66404.000.18 |