CAR-T 治疗前放疗预处理（REMIT）研究

Inclusion Criteria:

1. Written informed consent
2. Age ≥ 18 years
3. Histologically proven DLBCL, including transformed follicular or marginal zone lymphoma
4. Measurable disease on cross-sectional imaging that is at least 1.5cm in the longest diameter and measurable in two perpendicular dimensions
5. Relapsed/refractory after 2 or more standard immuno-chemotherapies
6. Approved to receive Tisagenlecleucel as per the licenced indication
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8. Disease accessible for repeat biopsies (Selected patients only)
9. Disease amenable to radiotherapy as assessed by the treating clinical oncologist
10. Willing and able to comply with the requirements of the protocol, including contraceptive advice as per the protocol

Exclusion Criteria:

1. Prior radiotherapy at location/dose that would interfere with application of radiotherapy or outcome measures in this trial
2. Women who are pregnant or breast feeding
3. Previous therapy with any genetically modified autologous or allogeneic T-cell immunotherapy, unless treated with doses of genetically modified autologous or allogeneic T-cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase I clinical trial

主要终点：Percentage of patients starting lymphodepletion on the planned start date without delay · To evaluate whether there is any delay in patients starting lymphodepletion · From planned start date of lymphodepletion until actual start date of lymphodepletion, assessed up to 2 weeks
次要终点：Best overall response after Tisagenlecleucel infusion as per International Working Group 2014 criteria；Overall response rate at 3 months and 6 months after Tisagenlecleucel infusion；Complete metabolic response at 3 months and 6 months after Tisagenlecleucel infusion；Duration of response；Median progression free survival and progression free survival at 12 months；Median event-free survival and event-free survival at 12 months；Median overall survival and overall survival at 12 months；Treatment emergent adverse events

• Bridging Radiotherapy · EXPERIMENTAL · Disease areas requiring effective long-term control will receive full-dose radiotherapy (20-30Gy/5-15#); other areas will receive low dose (4Gy/2#)

The REMIT trial will investigate radiotherapy as a preferred bridging method prior to Tisagenlecleucel infusion in patients with relapsed or refractory Diffuse Large B Cell Lymphoma