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| Name | Class |
|---|---|
| Hebei Medical University Fourth Hospital | OTHER |
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This study is a multicenter, non randomized, single arm, open clinical trial. The selected disease was relapsed / refractory NHL, and the disease was classified into highly aggressive lymphoma, invasive lymphoma and inert lymphoma; Highly invasive NHL included Burkitt lymphoma (BL), lymphoblastic lymphoma (LBL), high-grade B-cell lymphoma, etc; Invasive NHL includes diffuse large B-cell lymphoma, mantle cell lymphoma and peripheral T-cell lymphoma; Inert NHL contains follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto CAR-T | Experimental | Patients will be treated with Auto CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto CAR-T | Biological | Biological: Auto CAR-T |
| |
| Cyclophosphamide,Fludarabine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence and severity of adverse events | To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity | first one month after CAR-T infusion |
| Efficacy: Remission Rate | Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and unresponsive (NR) | 3 months post CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:duration of response (DOR) | duration of response (DOR) | 24 months after CAR-T infusion |
| Efficacy: progression-free survival (PFS) | progression-free survival (PFS) time |
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Inclusion Criteria:
Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visit, treatment plan, laboratory examination and other requirements of the study specified in the test flow sheet; 2. Patients with hematopoiesis and lymphoid tissue tumors diagnosed as relapsed and refractory by clinical diagnosis were defined as relapse or refractory
Primary drug resistance to standard treatment regimen;
Or PD occurred after at least second-line standard treatment;
Or the last treatment effect was SD and lasted no more than 6 months;
Or CD20 positive patients were ineffective or relapsed after anti-CD20 mAb treatment;
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Li, PhD & MD | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Baoen Shan, PhD & MD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Lihong Liu, PhD & MD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Department, Hebei Medical University Fourth Hospital | Recruiting | Shijiazhuang | Hebei | 050000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36275715 | Derived | 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. |
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| Drug |
Drug: Cyclophosphamide,Fludarabine |
|
| Leukapheresis | Procedure | Leukapheresis |
|
| 24 months after CAR-T infusion |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C095424 | CF regimen |
| D007937 | Leukapheresis |
| ID | Term |
|---|---|
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D047589 | Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
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