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NCT Number: NCT05514327

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Wei Zhang

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ultra-fraction radiotherapy

Radiation

the R/R DLBCL patients would receive ultra-fraction radiotherapy as bridging therapy before the CD19 CART cell infusion

Primary outcomes

  1. 3-month ORR

    Time frame: 3 months

    the overall response rate at 3 months after CAR-T cell infusion

Secondary outcomes

  1. 2-year PFS

    Time frame: 2 years

    the 2-year progression free survival time from CAR-T cell infusion

  2. 2-year OS

    Time frame: 2 years

    the 2-year overall survival time from CAR-T cell infusion

  3. 6-month ORR

    Time frame: 6 months

    the overall response rate at 6 months after CAR-T cell infusion

  4. DOR

    Time frame: 2 years

    the duration of response time

  5. relapse rate

    Time frame: 2 years

    the cumulative rate of relapse

  6. the rate of severe side effects

    Time frame: 2 years

    the rate of severe side effects (CTCAE≥ grade 3)

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Ruan, Docter

CONTACT

[email protected]

+8615201435860

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Aug 24, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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