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

Not Applicable

Recruiting

• Conditions: Bridging Therapy; Radiotherapy; Diffuse Large B Cell Lymphoma; CAR-T
• Interventions: Radiation: ultra-fraction radiotherapy

• Registration Number: NCT05514327
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Study Start: 2022-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	ultra-fraction radiotherapy	ultra-fraction radiotherapy + CAR-T

Primary Outcome Measures

Name	Time	Method
3-month ORR	3 months	the overall response rate at 3 months after CAR-T cell infusion

Secondary Outcome Measures

Name	Time	Method
2-year PFS	2 years	the 2-year progression free survival time from CAR-T cell infusion
DOR	2 years	the duration of response time
the rate of severe side effects	2 years	the rate of severe side effects (CTCAE≥ grade 3）
2-year OS	2 years	the 2-year overall survival time from CAR-T cell infusion
6-month ORR	6 months	the overall response rate at 6 months after CAR-T cell infusion
relapse rate	2 years	the cumulative rate of relapse

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China