CD30+ relapsed/refractory lymphoma
Conditions
Interventions
Treatment group:Infusion of anti CD30 CAR T cells
Sponsors
The First Affiliated Hospital of Zhengzhou University
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 the clinical research; 2. Aged >= 18 and = 1.5 cm, or the long axis is 1.0-1.5 cm and the short axis is >= 1.0 cm; 7. During screening, the laboratory examination of patients should meet the following requirements, and the interval of 2 weeks should be required for patients who have not received cell growth factor (long-term colony stimulating factor G-CSF/PEG-CSF) within 7 days before hematological evaluation, except recombinant erythropoietin: (1) Absolute value of neutrophil >= 1.0x10^9/L; (2) Hemoglobin >= 90 g/L, and hemoglobin of patients with bone marrow involvement >= 80 g/L; (3) Platelets in patients without bone marrow involvement >= 75x10 ^ 9/L, platelet of patients with bone marrow involvement >= 50x10^9/L; (4) Absolute lymphocyte (ALC) >= 0.5x10^9/L; (5) Total serum bilirubin = 60 mL/min; 8. There is no evidence to show that the subject has difficulty breathing at rest, and the measured value of pulse blood oxygen in indoor air is>90%; 9. The serum pregnancy test of women of childbearing age must be negative, and they must agree to take effective contraceptive methods at the same time from the signing of the informed consent form to 6 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Humanized CAR-T cell products are not subject to this restriction for those who have previously used any murine CAR-T cell products or other gene modified T cell therapies, but the interval between single collection and the last CAR-T cell infusion must be more than 3 months; 2. Have received autologous or allogeneic hematopoietic stem cell transplantation within 3 months; 3. Other malignant tumors (except basal cell carcinoma of skin, carcinoma in situ of breast/cervix and other malignant tumors that have not been treated and have been effectively controlled in the past five years); 4. Patients who have received continuous systemic steroids (prednisone>5mg/day or other hormones with equivalent dose) or other immunosuppressants within 14 days before single collection, except for recent or current use of inhaled steroids; 5. Hepatitis B (HBsAg positive and/or HBcAb positive and HBV DNA > 10 ^ 3 copies/mL) and hepatitis C (hepatitis C antibody test positive); Syphilis, human immunodeficiency disease (HIV) infection (HIV positive); 6. Patients with hyponatremia and/or hypokalemia, blood sodiumCTCAE 5.0 version Level 1), except alopecia and pigmentation; 13. Infusion of anti-CD30 and other anti-tumor antibodies within 4 weeks before single collection; 14. Before collection, he/she has received molecular therapy at any inhibitory/stimulatory immune checkpoint (anti-PD-1/PD-L1 monoclonal antibody, OX40 agonist, 4
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 ContactZhang Yi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed