To determine the factors that contribute to response to CAR T-cell therapy, both at the tumour-end, as well as on the T-cell side to understand mechanisms of efficacy and immune escape in order to optimize this treatment and to reduce toxicity
ID
Source
Brief title
Condition
- Haematological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall objective response rate
Correlation of cell free tumor DNA with ORR
T-cell persistence combined with immunological and metabolic phenotype
Observation of T-cell immune evasion mechanisms in tumor area
Secondary outcome
No secondary parameters
Background summary
Anti-CD19 CAR T-cell therapy has revolutionized the treatment of B-cell
lymphoma, B-ALL and B-CLL and two product are currently registered by EMA and
the FDA. Although results are impressive, not all patients benefit and toxicity
can be severe. Although several mechanisms of failure to respond to CAR T-cell
therapy and/or relapse following initial response are known, such as loss of
antigen, lack of persistence or T-cell exhaustion, we have limited
understanding of how we can predict failure or success. In order to get better
understanding of the mechanisms of CAR T-cell resistance we need to archive and
store blood and tissue, combined with clinical data, of all patients that are
undergoing this treatment.
Study objective
To determine the factors that contribute to response to CAR T-cell therapy,
both at the tumour-end, as well as on the T-cell side to understand mechanisms
of efficacy and immune escape in order to optimize this treatment and to reduce
toxicity
Study design
Prospective interventional study of patients that are treated with standard of
care CAR T-cell therapy for B-cell NHL
Study burden and risks
Peripheral blood will be collected at routine visits and toxicity visits. Extra
material will be collected but no additional vena puncture will have to be done
Tumor tissue will be collected necessary for diagnosis or confirmation of
relapse. If archival material is available and new biopsy is not feasible, this
material will be used.
At day 15 post infusion of CAR T-cells a biopsy will be attempted if risks for
patient are minimal.
If a patient developes 'immune effector cell (IEC) associated neurotoxicity
syndrome', a lumbar puncture will have to be performed as part of standard care
to exclude other causes of neurological complaints such as infection. as part
of this routine puncture an additional liquor tube will be collected.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
treatment of B-cell NHL with anti-CD19 CAR T-cel therapy
Exclusion criteria
no informed consent
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 |
---|---|
CCMO | NL74209.078.20 |