Relapsed and refractory B-cell lymphoma
Conditions
Interventions
Experimental group:Adebrelimab Injection with CAR-T Therapy
Sponsors
Chengdu Shang Jin Nan Fu Hospital / Shang Jin Hospital of West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16 to 75 years, male or female; 2. Patients who had B-cell lymphoma according to the WHO-HAEM5 classification, also relapsed and refractory after receiving 2 or more standard regimens; 3. At least one measurable lesion was present: nodal lesion longest diameter (LDi) > 1.5 cm or one extranodal lesion LDi > 1 cm (according to the 2014 edition Lugano classification); 4. ECOG=12 weeks; 7. Subjects of Women of Childbearing Potential had to have a blood pregnancy test within 7 days before the first dose, and the results were negative; WOCBP subjects and their male partners should agree to take effective contraception from the time they sign up for ICF until six months after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Patients allergic to Adabelimab; 2.Patients assessed as unsuitable for CAR-T therapy; 3.Medical history and comorbidities (1) The subject is complicated with other malignant tumors; (2) The subject has any active, known or suspected autoimmune disease. Allow subjects who are in a stable state and do not require systemic immunosuppressive therapy to be enrolled; (3) Subjects who require systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administering the investigational drug. In the absence of active autoimmune diseases, inhalation or topical use of steroids and adrenal hormone replacement at doses>10 mg/day of prednisone efficacy dose is allowed; (4) Known history of interstitial pneumonia; (5) History of concurrent interstitial lung disease or severe impairment of lung function; (6) Suffering from other malignant tumors within the past 5 years, excluding skin basal cell carcinoma, skin squamous cell carcinoma, breast in situ cancer, and cervical in situ cancer that have undergone radical treatment; (7) Received systemic anti-tumor therapy, including chemotherapy, immunotherapy, and biological therapy (such as tumor vaccines, cytokines, or growth factors that control cancer), within 28 days before starting the research treatment; (8) Subjects who have undergone major surgery or suffered severe trauma have had the effects of surgery or trauma eliminated for less than 28 days prior to enrollment; (9) Patients with active pulmonary tuberculosis (TB) need to be excluded. Patients suspected of having active TB should undergo chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs. Patients with a history of active pulmonary tuberculosis infection within the previous year, even if they have been treated, should be excluded; patients with a history of active pulmonary tuberculosis infection more than one year ago should also be excluded, unless it is proven that the course and type of anti tuberculosis treatment previously used were appropriate; (10) Severe acute or chronic infections that require systemic treatment; (11) Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); (12) Poor control of diabetes (FBG>10mmol/L); (13) Patients with heart failure (New York Heart Association standard III or IV) who, despite receiving appropriate medication, have poor coronary artery disease control or arrhythmia, or a history of myocardial infarction within the first 6 months of screening; (14) Patients with renal failure requiring hemodialysis or peritoneal dialysis; (15) Urine routine shows urinary protein >=++and confirms 24-hour urinary protein quantification>1.0 g; 4. Physical examination and laboratory examination findings: (1) Known to have a positive history of human immunodeficiency virus (HIV) test or known to have acquired immunodeficiency syndrome (AIDS); (2) Untreated active hepatitis (hepatitis B: hepatitis B surface antigen (HBsAg) positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) >= 500IU/mL; hepatitis C: hepatitis C virus (HCV) ribonucleic acid (RNA) positive with abnormal liver function; co-infection of hepatitis B and hepatitis C; 5. Patients with a long history of smoking; 6. Other situations deemed unsuitable for inclusion in the study by the researchers; 7. Pregnant or lactating fem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;CR duration;Progression-free survival;Overall survival, OS;Duration of relief, DOR;Adverse event; | — |
Countries
China
Contacts
Public ContactYongqian Jia
West China Hospital, Sichuan University
Outcome results
None listed