CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL

Korábbi kezelés

• Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion.
• Subjects of childbearing or child-fathering potential that are not willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the investigational product

Más betegség

• Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or increased risk of cytokine release syndrome.
• Known HIV infection or active Hepatitis B or Hepatitis C infection.

Laborértékek

• History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
  • Less than 100 days post-transplant;
  • Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
  • Less than 6 weeks post donor lymphocyte infusion (DLI).
• Evidence of severe organ dysfunction defined by:
  • Baseline oxygen saturation of < 90% on room air
  • Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings
  • Transaminases > 10x upper limit of normal (ULN) or bilirubin > 5x the ULN, unless thought to be related to primary disease
  • Estimated Creatinine (Cr) clearance < 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)

• Subjects must have a history of B precursor ALL with any of the following conditions:
  • Relapsed two or more times.
  • Relapsed at any time after allogeneic bone marrow transplant (BMT).
  • Relapse or refractory after single antigen targeting CAR T cell therapy.
  • 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and/or parents declining BMT options and would prefer CAR T Therapy.
• CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
• Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).
• Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.
• Males OR non-pregnant, non-lactating females.
• Aged 3 months to 30 years (inclusive) at time of consent and enrollment.
• Provision of a signed and dated consent form from parent or guardian (patients < 18), the patient themselves (> 18), or legally authorized representative (patient > 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Willingness to participate in long-term follow-up protocol.