Co-administration of CART22-65s and huCART19 for B-ALL
Use of Autologous Anti-CD22 CAR T Cells (CART22-65s) Co-administered With Humanized Anti-CD19 CAR T Cells (huCART19) in Children and Young Adults With Relapsed or Refractory B-ALL
Stephan Grupp MD PhD
93 participants
Jan 25, 2023
INTERVENTIONAL
Conditions
Summary
This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).
Eligibility
Inclusion Criteria10
- Signed informed consent form
- Patients with documented CD19+ and/or CD22+ ALL/LLy:
- Cohort A: Patients with relapsed or refractory ALL/LLy:
- Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
- Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
- Documentation of CD19 and/or CD22 tumor expression in bone marrow, peripheral blood, Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. If the patient has experienced a relapse after CD19-directed and/or CD22-directed therapy, flow cytometry should be evaluated after this therapy to demonstrate CD19 and/or CD22 expression.
- Age 0-29 years
- Adequate organ function
- Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
- Subjects of reproductive potential must agree to use acceptable birth control methods.
Exclusion Criteria7
- Active hepatitis B or active hepatitis C
- HIV infection
- Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
- Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
- Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity.
- Pregnant or nursing (lactating) women
- Uncontrolled active infection
Interventions
CART22-65s are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD22 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain
HuCART19 cells are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD19 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05674175