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

Last updated: January 15, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Lymphoma, B-cell

Cancer Treatment

Treatment

ultra-fraction radiotherapy

Clinical Study ID

NCT05514327
CART-1
  • Ages > 18
  • All Genders

Study 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

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 andanthracycline and either having failed autologous Hematopoietic stem celltransplantation (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

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. bloodculture 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 oractive hepatitis C( HCV RNA positive );
  7. Other conditions that the investigator may exclude due to risks or other possibilities

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: ultra-fraction radiotherapy
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
December 01, 2024

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

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