RecruitingNot ApplicableNCT05514327
A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL
the Safety and Efficacy of Ultra-fraction Radiotherapy Bridging CART Cell Therapy in Relapsed/Refractory Diffuse Large b Cell Lymphoma
Sponsor
Peking Union Medical College Hospital
Enrollment
20 participants
Start Date
Sep 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This is a single-arm single center study to prospectively evaluate the safety and efficacy of ultra-fraction radiotherapy bridging CAR-T therapy in relapsed/refractory diffuse large b cell lymphoma
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- Over than 18 years old
- Histologically confirmed DLBCL(by central pathology review before enrolment)
- Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT
- Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
- Life expectancy ≥12 weeks
- Able to receive radiotherapy evaluated by specialist
Exclusion Criteria7
- Prior radiation therapy within 1 year of infusion
- Pregnant or nursing (lactating) women
- Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
- Previous solid tumor within 3 years, previous or concurrent hematological malignancy
- Severe organ dysfunction: left ventricle ejection fraction (LVEF) <40%; DLCO <40%; estimated glomerular filtration rate (eGFR)<30mL/min/1.73 m2; total bilirubin >3 ULN
- HIV positive patients, active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive );
- Other conditions that the investigator may exclude due to risks or other possibilities
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Interventions
RADIATIONultra-fraction radiotherapy
the R/R DLBCL patients would receive ultra-fraction radiotherapy as bridging therapy before the CD19 CART cell infusion
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05514327
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