A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
• 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)
‣ a. 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.