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

Diffuse Large B Cell Lymphoma Radiotherapy CAR-T Bridging Therapy

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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