Status:
UNKNOWN
Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Yake Biotechnology Ltd.
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Detailed Description
Current studies have shown that under standard treatment, patients with large masses and high-grade DLBCL have a poor prognosis. Data from major centers around the world on CAR-T cell treatment of rel...
Eligibility Criteria
Inclusion
- Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmed include: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphoma Subject.
- R/R B-NHL (conform one of the following conditions)
- The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy
- Primary resistance
- The subject relapsed after receiving autologous hematopoietic stem cell transplantation
Exclusion
- Subjects with any of the following exclusion criteria were not eligible for this trial:
- 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;
- Those who have used any gene therapy products before.
- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
- Those who suffer from other uncontrolled diseases are not suitable to join the study;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05239676
Start Date
February 28 2022
End Date
December 1 2024
Last Update
February 15 2022
Active Locations (1)
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1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003