Status:
UNKNOWN
Sequential Radiotherapy With CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies With Extramedullary Lesions
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Yake Biotechnology Ltd.
Conditions:
Hematological Malignancies
Eligibility:
All Genders
15+ years
Phase:
PHASE1
PHASE2
Brief Summary
Clinical trial for the safety and efficacy of sequential radiotherapy with CAR-T cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions
Detailed Description
This is a prospective, single arm study. To evaluate the safety and efficacy of sequential radiotherapy with CAR-T cells in the treatment of relapsed and refractory hematological malignancies with ext...
Eligibility Criteria
Inclusion
- Age≥15 years old; Relapsed and refractory hematological malignancies with extramedullary lesions, mainly including B-cell non Hodgkin's lymphoma, multiple myeloma, acute lymphoblastic leukemia, etc; Flow cytometry or pathological biopsy confirmed that tumor cells have potential therapeutic targets for Car-T cells; PET-CT confirmed that the extramedullary lesions were located in a single radiotherapy region; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent.
Exclusion
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04790747
Start Date
March 1 2021
End Date
March 1 2025
Last Update
March 10 2021
Active Locations (1)
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1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310003