CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL

Korábbi kezelés

• Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；

Más betegség

• Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
• active bleeding, or venous thromboembolic event
• Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs
• Central nervous system (CNS) disease or symptoms of CNS involvement
• Any Iinappropriate conditions in the opinion of the PI .

Laborértékek

• Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h

Egyéb

• Pregnant or nursing (lactating) women
• Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded

• Male or female,≥18 years old;
• Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):
  • (B-NHL)
• Second or greater relapse (CD20 regimens must be included) OR
• Refractory to first-line chemotherapy or relapse within 1 year OR
• Relapse within 1 year of auto-HSCT.
• With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)
• Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.
• ECOG 0~2
• Estimated survival time ≥ 12 weeks;
• Main tissues and organs function well.