Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refracto… (NCT05979792) | Clinical Trial Compass
UnknownEarly Phase 1
Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma
China35 participantsStarted 2023-09-01
Plain-language summary
Despite the use of monoclonal antibodies, checkpoint inhibitors, and bispecific T cell adapters (BiTE) Immunotherapies such as chimeric antigen receptor (CAR) T cells have completely changed the treatment methods of various cancers.
However, only limited responses were observed in T cell diseases, In CD30 positive PTCL and CTCL patients. The use of BV in and pembroluzimab (Programmed cell death receptor 1) in the treatment of ENKTL.
Although some promising results have been observed for (PD-1) inhibitors, these positive results are limited to specific subtypes of T cell diseases.
CAR T Cell therapy in recurrent/refractory B-cell malignant tumors is very successful, the Food and Drug Administration (FDA) has approved two CAR T Cell therapy for the treatment of this type of disease. However, using this technology to treat T-cell malignancies has always been difficult, mainly due to the lack of tumor specific surface antigens in cancerous T cells.
Therefore, our center plans to conduct a phase I clinical study of CAR-T to explore the possibility of bringing more treatment options and benefits to PTCL patients.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old and\<80 years old.
✓. According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell lymphoma, including but not limited to: peripheral T Cell lymphoma, non-specific type (PTCL-NOS), anaplastic large cell lymphoma (ALCL), T helper cell lymphoma (FTCL), peripheral lymph nodes with follicular helper T cell phenotype T-cell lymphoma (TFH) and angioimmunoblastic T-cell lymphoma (AITL), Etc;
✓. Relapse or refractory peripheral T-cell lymphoma, which requires at least 2 systematic Sex therapy, is invalid or relapses.
✓. Histologically confirmed as CD7 positive.
✓. According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion (with the longest diameter of the intranodal lesion\>1.5cm and the longest diameter of the extranodal lesion\>1.0cm), and PET/CT should show metabolic activity.
✓. Blood routine neutrophil count ≥ 1.0 during screening × 109/L; For individuals without bone marrow invasion, platelet count ≥ 75 × 109/L, Hb ≥ 80g/L; For individuals with bone marrow invasion, platelet count ≥ 50 × 109/L, Hb ≥ 60g/L (if the patient does not meet the screening requirements but meets the screening period requirements for re examination, they can be selected).
. The average fluorescence intensity (MFI) of donor specific antibodies (DSA) at HLA sites of HLA antibody negative or anti RD13-02 cell derived donors is less than 2000.
✓. Creatinine clearance rate\>60ml/min (Cockcroft and Gault formula); For patients without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal value, and serum ALT and AST ≤ 3 times the upper limit of normal value range; For patients with liver invasion, serum total bilirubin ≤ 3 times the upper limit of normal value, and serum ALT and AST ≤ 5 times the upper limit of normal value range.
Exclusion criteria
✕. Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); Enteropathy associated T-cell lymphoma (EATL), monotypic epitheliophagocytic intestinal T-cell lymphoma (MEITL), hepatosplenic T-cell lymphoma (HSTCL), extranodal NK/T-cell lymphoma, nasal type (EENKTCL) and primary central nervous system lymphoma and other types of T-cell leukemia/lymphoma.
✕. Active central nervous system (CNS) invasion.
✕. If anti-tumor treatment has been received before infusion, it should be excluded if any of the following conditions are met:
✕. Individuals with a history of allergies to any component in cellular products.
✕. According to the New York Heart Association (NYHA) cardiac function grading standards, subjects with cardiac dysfunction classified as Class III or IV.
✕. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart disease clinically within 12 months of enrollment.
✕. The electrocardiogram indicates that the QT interval is significantly prolonged, and the patient has serious heart disease such as serious arrhythmia in the past.
✕. Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.