Clinical trial NCT04790747: Sequential Radiotherapy With CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies With Extramedullary Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hematological Malignancies
Keywords: radiotherapy
CAR-T
extramedullary lesions
relapsed and refractory
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yake Biotechnology Ltd.
First posted: 2021-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 extramedullary lesions. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Baseline up to 28 days after CAR-T cells infusion
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 2 years after CAR-T cells infusion
Secondary outcomes:
measure: Complete Remission Rate
timeFrame: up to 28 days after CAR-T cells infusion
measure: Overall survival (OS)
timeFrame: Up to 2 years after CAR-T cells infusion
measure: Disease-free survival (DFS)
timeFrame: Up to 2 years after CAR-T cells infusion
measure: Quality of life
timeFrame: At Baseline, Month 1, 3, 6, 9 and 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Hospital of Zhejiang Medical Colleage Zhejiang University
state: Zhejiang
Study officials:
References: