A Multicenter Clinical Study on the Safety and Efficacy of CAR-T in the Treatment of Relapsed / Refractory Non Hodgkin's Lymphoma
NCT ID: NCT04666168
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-10-22
2025-10-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Auto CAR-T
Patients will be treated with Auto CAR-T cells
Auto CAR-T
Biological: Auto CAR-T
Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine
Leukapheresis
Leukapheresis
Interventions
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Auto CAR-T
Biological: Auto CAR-T
Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine
Leukapheresis
Leukapheresis
Eligibility Criteria
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Inclusion Criteria
1. Primary drug resistance to standard treatment regimen;
2. Or PD occurred after at least second-line standard treatment;
3. Or the last treatment effect was SD and lasted no more than 6 months;
4. Or CD20 positive patients were ineffective or relapsed after anti-CD20 mAb treatment;
5. Or PD after autologous hematopoietic stem cell transplantation, or recurrence confirmed by biopsy within 12 months, or salvage treatment after autologous hematopoietic stem cell transplantation has no remission or recurrence after treatment.
3\. According to RECIST version 1.1 , there should be at least one measurable tumor focus; 4. Subjects with ECoG score of 0-2 5. 14 years old ≤ age ≤ 75 years old, both male and female; 6. The tumor cells were positive for CD19 or CD22 / CD30 / CD7 / CD79 by immunohistochemistry or flow cytometry; 7. The expected survival time is more than 3 months from the date of signing the informed consent； 8. Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 10\^9/L, absolute neutrophil count (ANC) ≥1.0 × 10\^9/L, if the investigator believes that the above inspection value is below the lower limit It is caused by tumor invading bone marrow and can be included in the group after consultation with the sponsor; 9. The main organ function indicators meet the following conditions: AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN, serum creatinine ≤1.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection fraction (LVEF) ≥50%, and minimum pulmonary function reserve (dyspnea is not higher than level 1 and blood oxygen saturation\> 92% under indoor conditions).
Exclusion Criteria
2. There is a history of severe lung dysfunction diseases;
3. The patient has had other malignant tumors in the past 5 years, except for skin basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment;
4. Combined with severe or persistent infection and cannot be effectively controlled; Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, and can be included in the group after infection is controlled
5. Combined metabolic diseases (except diabetes);
6. Combined with severe autoimmune disease or innate immune deficiency;
7. Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody \[ HCV-Ab\] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and C co-infection;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
9. A history of severe allergies to biological products (including antibiotics);
10. Participate in any other clinical drug trials at the same time within one month;
11. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.
14 Years
75 Years
ALL
No
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Hebei Senlang Biotechnology Inc., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Baoen Shan, PhD & MD
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Fourth Hospital
Lihong Liu, PhD & MD
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Fourth Hospital
Locations
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Hematology Department, Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Lihong Liu, PhD & MD
Role: primary
References
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Zhang W, Huang C, Liu R, Zhang H, Li W, Yin S, Wang L, Liu W, Liu L. Case report: CD19-directed CAR-T cell therapy combined with BTK inhibitor and PD-1 antibody against secondary central nervous system lymphoma. Front Immunol. 2022 Oct 5;13:983934. doi: 10.3389/fimmu.2022.983934. eCollection 2022.
Other Identifiers
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2020102
Identifier Type: -
Identifier Source: org_study_id