Ultra-fraction radiotherapy before CAR-T therapy for relapsed DLBCL

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

This study is testing if a special type of radiation treatment before CAR-T therapy can help people with hard-to-treat diffuse large B cell lymphoma feel better and have better results.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: rituximab, chemotherapy, radiation, CAR-T
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05514327 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of ultra-fraction radiotherapy as a bridging treatment before CAR-T therapy in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). It is a single-arm, single-center study conducted at Peking Union Medical College Hospital. Participants must have measurable disease and have previously undergone at least two lines of chemotherapy. The goal is to determine if this approach can improve outcomes for patients who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with histologically confirmed relapsed or refractory DLBCL who have failed multiple lines of chemotherapy.

Not a fit: Patients who have received prior radiation therapy within the last year or have severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment efficacy and improve survival rates for patients with relapsed DLBCL.

How similar studies have performed: While there have been studies on CAR-T therapy and radiotherapy separately, this specific approach of ultra-fraction radiotherapy as a bridging therapy is novel and has not been extensively tested.

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

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jing Ruan, Docter

Conditions: Diffuse Large B Cell Lymphoma, CAR-T, Radiotherapy, Bridging Therapy