Enhancing CAR T-cell therapy through cellular imaging and radiotherapy.
Il Minn, Steven P Rowe, Martin G Pomper
https://pubmed.ncbi.nlm.nih.gov/31364596Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05514327
Safety and Efficacy of Ultra-fraction Radiotherapy Bridging CAR-T Cell Therapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma
Led by Peking Union Medical College Hospital · Updated on 2026-03-24
20
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ultra-fraction radiotherapy combined with CAR-T cell therapy in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). This single-center, single-arm study focuses on patients who have not responded to at least two lines of chemotherapy and may have failed or are ineligible for stem cell transplantation. Participants receive ultra-fraction radiotherapy as a bridging treatment before the infusion of CD19 CAR-T cells. The study involves this combined treatment approach to assess its potential benefits and risks in managing DLBCL that has returned or not responded to previous therapies. During the study, participants will be monitored for treatment response at 3 and 6 months, as well as for progression-free survival, overall survival, duration of response, relapse rate, and severe side effects over a two-year period. Evaluations include assessing measurable disease, patient safety, and therapeutic effectiveness throughout follow-up visits lasting up to two years after treatment initiation.
CONDITIONS
Brief Title
A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Histologically confirmed diffuse large B cell lymphoma by central pathology review before enrollment
- Relapsed or refractory disease after at least 2 lines of chemotherapy including rituximab and anthracycline
- Failed autologous hematopoietic stem cell transplantation (ASCT), or ineligible for or not consenting to ASCT
- Measurable disease at enrollment with maximum cross section diameter of at least 1.5 cm
- Life expectancy of at least 12 weeks
- Able to receive radiotherapy as evaluated by a specialist
You will not qualify if you...
- Prior radiation therapy within 1 year before infusion
- Pregnant or nursing (lactating) women
- Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., positive blood culture within 72 hours before infusion)
- Previous solid tumor within 3 years or previous/concurrent hematological malignancy
- Severe organ dysfunction including left ventricle ejection fraction less than 40%, DLCO less than 40%, estimated glomerular filtration rate less than 30 mL/min/1.73 m2, or total bilirubin greater than 3 times the upper limit of normal
- HIV positive patients or active replication/prior infection with hepatitis B or active hepatitis C (HCV RNA positive)
- Other conditions that the investigator may exclude due to risks or other concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Until CAR-T cell infusion
Participants receive ultra-fraction radiotherapy as bridging therapy before CAR-T cell infusion.
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
J
Jing Ruan, Docter
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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