CD30+ relapsed/refractory lymphoma
Conditions
Interventions
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Understand and sign the informed consent form and voluntarily participate in clinical research; 2. Aged 18-70 years, gender is not limited; 3. Patients with relapsed or refractory CD30+ lymphoma who have received at least 2 lines of systemic therapy in the past, including but not limited to: (1) Hodgkin lymphoma; (2) Mature T-cell lymphoma, including but not limited to peripheral T-cell lymphoma-unspecified, angioimmunoblastic T-cell lymphoma, NK/T-cell lymphoma, anaplastic large cell lymphoma; (3) Diffuse large B-cell lymphoma, including but not limited to mediastinal B-cell lymphoma, gray zone lymphoma; (4) Other lymphoproliferative tumors; 4. The patient's Eastern Cooperative Oncology Group (ECOG) performance status score must be 0 or 1; 5. Have sufficient venous access (for apheresis), and have no other contraindications for blood cell separation; 6. According to the revised version of the evaluation of malignant lymphoma (2018 Lugano criteria), fluorodeoxyglucose-PET positive or enhanced CT detection has at least one quantifiable lesion: the long axis of the lesion is >=1.5 cm, or long axis 1.0-1.5 cm and short axis >= 1.0 cm; 7. When the patient is being screened, the laboratory examination must meet the following requirements, and the patient has not received cell growth factor (long-acting colony-stimulating factor G-CSF/PEG-CSF) within 7 days before the hematological evaluation, and an interval of 2 weeks is required. Except for recombinant erythropoietin: (1) The absolute value of neutrophils is >= 1.0x10^9/L; (2) Hemoglobin >= 90 g/L (without red blood cell transfusion within 14 days), hemoglobin >= 75 g/L in patients with bone marrow involvement; (3) Platelets in patients without bone marrow involvement >= 75 x 10^9/L, and platelets in patients with bone marrow involvement >= 50 x 10^9/L; (4) Absolute lymphocytes (ALC) >= 0.3x10^9/L; (5) Serum total bilirubin = 60 mL/min; 8. There is no evidence that the subject has difficulty breathing at rest, and the pulse oximetry value on room air is > 90%; 9. Women of childbearing age must have a negative serum pregnancy test, and must agree to take effective contraceptive methods from the time of signing the informed consent to 6 months after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of allergy to any component in the cell product; 2. Those who have previously used any CAR-T cell products or other genetically modified T cell therapies; 3. Received autologous or allogeneic hematopoietic stem cell transplantation within 3 months; 4. Suffering from other malignant tumors in the past or present at the same time (except skin basal cell carcinoma, breast/cervical carcinoma in situ and other malignant tumors that have been effectively controlled without treatment in the past five years); 5. Patients who have received continuous systemic steroids (prednisone > 5mg/day or equivalent doses of other hormones) or other immunosuppressants within 14 days before apheresis, except for recent or current use of inhaled steroids; 6. Hepatitis B (positive for hepatitis B virus surface antigen and/or positive for hepatitis B core antibody and hepatitis B DNA > 10^3 copies/mL) and hepatitis C (positive for hepatitis C antibody test); 7. Syphilis, human immunodeficiency disease (HIV) infection (HIV positive); 8. Patients with hyponatremia and/or hypokalemia, serum sodium CTCAE version 5.0 grade 1), except for alopecia and pigmentation; 15. Infusion of anti-CD30 and other anti-tumor antibodies within 4 weeks before apheresis; 16. Received any previous systemic inhibitory/stimulatory immune checkpoint molecule therapy (anti-PD-1/PD-L1 monoclonal antibody), and within 3 half-lives; 17. Use of immunostimulatory or suppressive therapy (such as interferon-alpha, interferon-beta, IL-2, etanercept, infliximab, tacrolimus, cyclosporine or mycophenolic acid); 18. Use short-acting targeted therapy (such
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Remission Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of Response (DOR);Progression Free Survival (PFS);Overall Survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactHu Sheng
Hubei Cancer Hospital
Outcome results
None listed