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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05514327
Other study ID # CART-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 1, 2024

Study information

Verified date January 2024
Source Peking Union Medical College Hospital
Contact Jing Ruan, Docter
Phone +8615201435860
Email ruanjing@pumch.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

DeSelm C, Palomba ML, Yahalom J, Hamieh M, Eyquem J, Rajasekhar VK, Sadelain M. Low-Dose Radiation Conditioning Enables CAR T Cells to Mitigate Antigen Escape. Mol Ther. 2018 Nov 7;26(11):2542-2552. doi: 10.1016/j.ymthe.2018.09.008. Epub 2018 Sep 13. — View Citation

Kuhnl A, Roddie C, Kirkwood AA, Tholouli E, Menne T, Patel A, Besley C, Chaganti S, Sanderson R, O'Reilly M, Norman J, Osborne W, Bloor A, Lugthart S, Malladi R, Patten PEM, Neill L, Martinez-Cibrian N, Kennedy H, Phillips EH, Jones C, Sharplin K, El-Sharkawi D, Latif AL, Mathew A, Uttenthal B, Stewart O, Marzolini MAV, Townsend W, Cwynarski K, Ardeshna K, Ardavan A, Robinson K, Pagliuca A, Collins GP, Johnson R, McMillan A. A national service for delivering CD19 CAR-Tin large B-cell lymphoma - The UK real-world experience. Br J Haematol. 2022 Aug;198(3):492-502. doi: 10.1111/bjh.18209. Epub 2022 Apr 29. — View Citation

Manjunath SH, Cohen AD, Lacey SF, Davis MM, Garfall AL, Melenhorst JJ, Maxwell R, Arscott WT, Maity A, Jones JA, Plastaras JP, Stadtmauer EA, Levine BL, June CH, Milone MC, Paydar I. The Safety of Bridging Radiation with Anti-BCMA CAR T-Cell Therapy for Multiple Myeloma. Clin Cancer Res. 2021 Dec 1;27(23):6580-6590. doi: 10.1158/1078-0432.CCR-21-0308. Epub 2021 Sep 15. — View Citation

Minn I, Rowe SP, Pomper MG. Enhancing CAR T-cell therapy through cellular imaging and radiotherapy. Lancet Oncol. 2019 Aug;20(8):e443-e451. doi: 10.1016/S1470-2045(19)30461-9. Epub 2019 Jul 29. — View Citation

Qu C, Ping N, Kang L, Liu H, Qin S, Wu Q, Chen X, Zhou M, Xia F, Ye A, Kong D, Li C, Yu L, Wu D, Jin Z. Radiation Priming Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma With High Tumor Burden. J Immunother. 2020 Jan;43(1):32-37. doi: 10.1097/CJI.0000000000000284. — View Citation

Sim AJ, Jain MD, Figura NB, Chavez JC, Shah BD, Khimani F, Lazaryan A, Krivenko G, Davila ML, Liu HD, Falchook AD, Dahiya S, Rapoport AP, Kim S, Locke FL, Robinson TJ. Radiation Therapy as a Bridging Strategy for CAR T Cell Therapy With Axicabtagene Ciloleucel in Diffuse Large B-Cell Lymphoma. Int J Radiat Oncol Biol Phys. 2019 Dec 1;105(5):1012-1021. doi: 10.1016/j.ijrobp.2019.05.065. Epub 2019 Jun 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 3-month ORR the overall response rate at 3 months after CAR-T cell infusion 3 months
Secondary 2-year PFS the 2-year progression free survival time from CAR-T cell infusion 2 years
Secondary 2-year OS the 2-year overall survival time from CAR-T cell infusion 2 years
Secondary 6-month ORR the overall response rate at 6 months after CAR-T cell infusion 6 months
Secondary DOR the duration of response time 2 years
Secondary relapse rate the cumulative rate of relapse 2 years
Secondary the rate of severe side effects the rate of severe side effects (CTCAE= grade 3) 2 years
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