Status:
UNKNOWN
Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsors:
Beijing Lu Daopei Hospital
Hebei Yanda Ludaopei Hospital
Conditions:
Non-hodgkin's Lymphoma
Eligibility:
All Genders
3-70 years
Phase:
NA
Brief Summary
This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.
Detailed Description
The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of ...
Eligibility Criteria
Inclusion
- Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
- There should be at least one measurable tumor focus according to the RECIST version 1.1;
- ECOG Scores: 0\~2;
- The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
- Estimated survival time was longer than 3 months;
- main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation \>92%；
- Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
Exclusion
- Serious cardiac insufficiency；
- Has a history of severe pulmonary function damaging;
- With other tumors which is/are in advanced malignant and has/have systemic metastasis;
- Merging the metabolic diseases (except diabetes);
- Merging severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C virus infection;
- Patients with HIV infection or syphilis infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Participated in any other clinical drug trial for the last six months;
- Being pregnant and lactating or having pregnancy within 12 months;
- With other uncontrolled diseases and considered not suitable to participate by the researchers;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04447547
Start Date
June 30 2020
End Date
December 30 2022
Last Update
September 29 2020
Active Locations (2)
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1
BeiJing Ludaopei Hospital
Beijing, Yizhuang, China, 100000
2
He bei Yan da Lu dao pei Hospital
Yanda, China