Clinical Study of Anti-CD56-CAR-T in the Treatment of Relapsed/Refractory NK/T Cell Lymphoma /NK Cell Leukemia
Single-center, Open, One-arm Clinical Study of the Safety and Efficacy of Anti-CD56-CAR T Therapy in Relapsed Refractory NK/T Cell Lymphoma /NK Cell Leukemia
The Affiliated Hospital of Xuzhou Medical University
20 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
To evaluate the safety and efficacy of anti-CD56-CAR T in the treatment of relapsed refractory NK/T cell lymphoma /NK cell leukemia
Eligibility
Inclusion Criteria15
- Patients or their legal guardians voluntarily participate and sign the informed consent;
- Male or female patients aged 18-70 years (including 18 and 70 years);
- The patient was diagnosed as NK/T cell lymphoma /NK cell leukemia by pathology or flow cytometry, and currently has no effective treatment options, such as relapse after chemotherapy or hematopoietic stem cell transplantation; Alternatively, patients voluntarily choose to administer anti-CD56-CAR T cells as salvage therapy.
- The following two categories are included:(1)NK/T cell lymphoma;(2) NK cell leukemia.
- Subject:
- (1)There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable; (2)Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable; (3)Patients with high risk factors; (4)Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
- \. Measurable or evaluable lesions;
- \. The patient's main tissues and organs function well:
- Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
- Renal function: creatinine \< 220 μmol/L;
- Lung function: indoor oxygen saturation ≥95%;
- Cardiac function: left ventricular ejection fraction (LVEF) ≥40%.
- \. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss);
- \. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion;
- \. Patients with ECOG score ≤2 and expected survival time ≥3 months.
Exclusion Criteria13
- Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding;
- Men or women who have planned to become pregnant within the last 1 year;
- The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment;
- Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
- Active hepatitis B/C virus;
- HIV-infected patients;
- Suffering from a serious autoimmune disease or immunodeficiency disease;
- The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;
- The patient had participated in other clinical trials within 6 weeks prior to enrollment;
- Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
- Suffers from mental illness;
- The patient has substance abuse/addiction;
- According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion.
Interventions
CAR T cells were pretreated at -5 days before retransfusion (FC regimen: fludarabine: 30mg/m2×3 days, cyclophosphamide: 750mg/m2×1 day). Anti CD56-CAR T cells were transfused back to the patient 2 days after the end of chemotherapy. 30 to 60 minutes before CAR T cell infusion, patients were given 325 to 650 mg of acetaminophen orally to prevent infusion-related reactions; If fever occurred on the day of CAR T cell infusion, lasted less than 24 hours, and had no other toxicity, it was attributed to the infusion T cell response.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05941156