CRISPR (HPK1) Edited CD19-specific CAR-T Cells (XYF19 CAR-T Cells) for CD19+ Leukemia or Lymphoma.

This is an interventional treatment trial for Leukemia Lymphocytic Acute (ALL) in Relapse focused on measuring Leukemia Lymphocytic Acute, Lymphoma, B-Cell Read More

Inclusion Criteria:

• Subject must meet all the following criteria to be selected:

  1. Willing to provide consent/assent for participation in the study by patient or his/her legal guardian;
  2. Male or Female subjects age ≥18 and ≤55 years;
  3. Evidence of relapsed/refractory CD19+ B cell hematological malignancies. The most common relapsed/refractory B cell hematological malignancies include: (1) B cell acute lymphoblastic leukemia (B-ALL); (2) B cell lymphomas, including indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL) and aggressive B cell lymphoma (DLBCL, BL, MCL)；

  4. Subjects (20 subjects of B cell acute lymphoblastic leukemia and 20 subjects of B cell lymphoma) with the following conditions:

     1. Failure to achieve complete remission (CR) after at least two lines of standard chemotherapy while not suitable for HSCT (auto/allo-HSCT)；
     2. Relapse after CR, but not eligible for HSCT (auto/allo-HSCT);
     3. Failure to achieve remission or relapse after HSCT;
  5. Leukemia patient confirmed by bone marrow aspiration that has not been alleviated; lymphoma patient with measurable or assessable lesions;

  6. Adequate organ function:

     1. Liver: ALT/AST ≥ 3 × ULN, total bilirubin ≤34.2 mol/L;
     2. Kidney: Creatinine<220 µmol/L, creatinine clearance rate (CCR) ≥ 60 mL/min;
     3. Lung: arterial oxygen saturation ≥95%;
     4. Heart: Left ventricular ejection fraction (LVEF) ≥40%;
     5. Absolute lymphocyte count (ALC) ≥ 100/μL, absolute neutrophil count (ANC) ≥ 1,000/μL, platelets (PLT) ≥ 75,000/μL;
  7. No prior anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (immunosuppression) within 4 weeks prior to enrollment, and toxic reactions of all prior treatments recovered to grade ≤1 at the time of enrollment (except for low toxicity such as alopecia);
  8. Presence of smooth peripheral superficial venous blood flow to fulfill intravenous infusion;
  9. Karnofsky performance score ≥60; ECOG ≤2; estimated survival ≥3 months.

Exclusion Criteria:

• Subjects meeting one or more of the following criteria will be excluded:

  1. Female patient who is pregnant or breastfeeding ;
  2. Male or Female patient within Pregnancy Program in 1 year;
  3. Unwilling or unable to guarantee effective contraceptive measures (condoms or contraceptives) within 1 year after enrollment;
  4. Presence of uncontrolled infectious disease within 4 weeks prior to enrollment:
  5. Active hepatitis B or hepatitis C infection;
  6. HIV infection;
  7. Active TB;
  8. Presence of active malignancy other than disease under study, confirmed by pathology;
  9. Severe autoimmune diseases or immunodeficiency;
  10. Suffering from allergies;
  11. Joining another clinical trial within 6 weeks prior to enrollment;
  12. Using systemic corticosteroid within 4 weeks prior to enrollment (except for those who use inhaled steroids);
  13. Psychiatric disorders;
  14. History of epilepsy and seizures or other CNS pathology;
  15. Addiction to or abuse of drugs;
  16. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol.