A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: CAR-T; Radiotherapy; Bridging Therapy; Diffuse Large B Cell Lymphoma

Treatments: Radiation: ultra-fraction radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05514327

CART-1

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over than 18 years old
2. Histologically confirmed DLBCL(by central pathology review before enrolment)
3. 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
4. Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
5. Life expectancy ≥12 weeks
6. Able to receive radiotherapy evaluated by specialist

Exclusion criteria

1. Prior radiation therapy within 1 year of infusion
2. Pregnant or nursing (lactating) women
3. Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
4. Previous solid tumor within 3 years, previous or concurrent hematological malignancy
5. 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
6. HIV positive patients, active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive );
7. Other conditions that the investigator may exclude due to risks or other possibilities

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment group

Experimental group

Description:

ultra-fraction radiotherapy + CAR-T

Treatment:

Radiation: ultra-fraction radiotherapy