Relapsed/refractory CD19-positive B-cell hematological malignancies
Conditions
Interventions
Level 1:5.0×10^7 CAR19 iNKT cells therapy
Level 2:10×10^7 CAR19 iNKT cells therapy
Level 3:5.0×10^8 CAR19 iNKT cells therapy
Level 4:10×10^8 CAR19 iNKT cells therapy
Sponsors
Nanfang Hospital Ganzhou Hospital (Ganzhou People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The participants voluntarily participate in this clinical research, fully understand the study details and have signed the informed consent form, as well as comply with all research procedures; 2. Between 18 and 75 years of age (inclusive), both genders are eligible; 3. Patients with refractory or relapsed acute B-cell lymphoblastic leukemia and B-cell lymphoma, diagnosed in accordance with the WHO 2016 classification; 4. CD19 positivity confirmed by flow cytometry and/or histopathology; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1; 6. Estimated survival >12 weeks; 7. Any prior systemic therapy (excluding immune checkpoint inhibitors) must have elapsed at least 2 weeks or 5 half-lives (whichever is shorter) prior to the planned study treatment. For any prior immune checkpoint inhibitor therapy (e.g., anti-PD-1 or PD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), at least 3 half-lives or 28 days must have elapsed prior to the planned study treatment (whichever is shorter); 8. Toxicity from prior therapy must have stabilized and resolved to Grade =1, excluding clinically insignificant toxicities such as alopecia; 9. Adequate renal, hepatic, pulmonary, and cardiac function, defined as: Creatinine clearance rate (estimated by Cockcroft-Gault) >=60 mL/min; Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) =50%; echocardiogram (ECHO) showing no evidence of pericardial effusion; and no clinically significant electrocardiogram (ECG) abnormalities; No clinically significant pleural effusion; Baseline oxygen saturation measured at room air >92%; 10. Female of childbearing potential must have a negative serum or urine pregnancy test.(Women who are surgically sterilized or postmenopausal for at least 2 years are not considered to have childbearing potential.) Use a highly effective and reliable method of contraception for 1 year following receipt of study treatment. Absolutely prohibited from donating eggs for 1 year following receipt of study treatment infusions during the study period; 11. Male participants who have active sexual intercourse with women of childbearing potential must agree to use a highly effective and reliable method of contraception for 1 year following receipt of study treatment. All male participants are absolutely prohibited from donating sperm for 1 year following receipt of study treatment infusions during the study period.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of central nervous system (CNS) leukemia/lymphoma, or those with CNS leukemia/lymphoma identified by screening magnetic resonance imaging (MRI) or PET-CT intracranial imaging, or detected malignant cells in cerebrospinal fluid or brain metastases; 2. Patients with a history of testicular leukemia/lymphoma and screening imaging examination indicating active testicular leukemia/lymphoma; 3. Patients with a history of other unresolved malignancies within the past 5 years or concurrent unresolved malignancies, excluding those with fully treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma =500 ms corrected by Bazett's formula recommended, subject to investigator judgment), poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), poorly controlled diabetes mellitus, pulmonary embolism, diffuse pulmonar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy; | — |
Countries
China
Contacts
Public ContactHongsheng Zhou
Nanfang Hospital Ganzhou Hospital (Ganzhou People's Hospital)
Outcome results
None listed