An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Pati… (NCT05208853) | Clinical Trial Compass
UnknownEarly Phase 1
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma
China9 participantsStarted 2022-02-10
Plain-language summary
This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Understand and sign the informed consent form, and voluntarily participate in clinical study;
✓. 18-70 years old, no gender limit;
✓. Patients with CD30+ lymphoma have received at least 2-line systemic treatment in the past and who have relapsed or are refractory, including but not limited to:
✓. Hodgkins lymphoma;
✓. Mature T-cell lymphoma, including but not limited to non-specific peripheral T cell lymphoma, angioimmunoblastic T-cell lymphoma, NK/T-cell lymphoma, anaplastic large-cell lymphoma;
✓. Diffuse large B-cell lymphoma, including but not limited to mediastinal B-cell lymphoma, gray zone lymphoma;
✓. Other lymphocytic proliferative tumors;
✓. Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1;
Exclusion criteria
✕. Patients have a history of allergies to any component in cell therapy products.
✕. Patients received any CAR-T cell product or other genetically modified T cell therapy in the past.
✕. Patients received autologous or allogeneic hematopoietic stem cell transplantation within 3 months.
✕. Patients suffering from other malignant tumors in the past or present (except for skin basal cell carcinoma, breast/cervix carcinoma in situ and other malignant tumors that have not been treated and effectively controlled in the past five years).
✕. Patients who have received continuous systemic steroids (prednisone\> 5 mg/day or equivalent doses of other hormones) or other immunosuppressive agents within 14 days before apheresis, except those who have recently or currently used inhaled steroids.
✕. Patients with Hepatitis B (positive hepatitis B virus surface antigen and/or positive hepatitis B core antibody and hepatitis B DNA \> 10\^3 copies/mL) and Hepatitis C (positive hepatitis C antibody test).
✕. Patients with syphilis, human immunodeficiency virus (HIV) infection (HIV positive).
✕. Patients with hyponatremia and/or hypokalemia, blood sodium \< 125 mmol/L and/or blood potassium \< 3.5 mmol/L (Except that blood sodium and/or potassium were restored above this level by sodium and/or potassium supplementation before participating in this study).