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

March 23, 2026 updated by: Ruanjing, Peking Union Medical College Hospital

the Safety and Efficacy of Ultra-fraction Radiotherapy Bridging CART Cell Therapy in Relapsed/Refractory Diffuse Large b Cell Lymphoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
ultra-fraction radiotherapy + CAR-T
Radiation: ultra-fraction radiotherapy
the R/R DLBCL patients would receive ultra-fraction radiotherapy as bridging therapy before the CD19 CART cell infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-month ORR
Time Frame: 3 months
the overall response rate at 3 months after CAR-T cell infusion
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CART-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study protocol, statistical analysis plan, informed consent form, clinical study report would be available upon email request in 3 years after the closure of the study

IPD Sharing Time Frame

3 years after the closure of the study

IPD Sharing Access Criteria

upon email request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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