Last updated: February 13, 2022
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Lymphoma
Treatment
N/AClinical Study ID
NCT05239676
AUTO-CART-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 1.Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmedinclude: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/smalllymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphomaSubject. 3.R/R B-NHL (conform one of the following conditions)
- The subject did not remission or relapsed after receiving second-line orhigher-line chemotherapy
- Primary resistance
- The subject relapsed after receiving autologous hematopoietic stem celltransplantation
Exclusion
Exclusion Criteria:
- Subjects with any of the following exclusion criteria were not eligible for thistrial:
- History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such assevere arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infectionand 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-stimulationsignal;
- 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 thestudy;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients orinterfere with the test results.
Study Design
Total Participants: 50
Study Start date:
February 28, 2022
Estimated Completion Date:
December 01, 2024
Study Description
Connect with a study center
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting

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