NCT05514327 A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL
| NCT ID | NCT05514327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-09-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05514327 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05514327 currently recruiting?
Yes, NCT05514327 is actively recruiting participants. Contact the research team at ruanjing@pumch.cn for enrollment information.
Where is the NCT05514327 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05514327 clinical trial?
NCT05514327 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 20 participants.