Status:

RECRUITING

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

Lead Sponsor:

Peking Union Medical College Hospital

Conditions:

Diffuse Large B Cell Lymphoma

CAR-T

Eligibility:

All Genders

18+ years

Phase:

NA

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

Key Trial Info

Start Date :

September 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05514327

Start Date

September 1 2022

End Date

December 1 2028

Last Update

March 24 2026

Active Locations (1)

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

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