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Recruiting
NCT05674175
Co-administration of CART22-65s and huCART19 for B-ALL
Conditions: B-cell Acute Lymphoblastic Leukemia, B Lineage Lymphoblastic Lymphoma
Sex: All
Ages: N/A – 29 Years
Phase: PHASE1, PHASE2
Enrollment: 93
Sponsor: Stephan Grupp MD PhD
Location: United States
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 Criteria
Inclusion Criteria:Signed informed consent formPatients 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 therapyPatients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapyDocumentation 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 yearsAdequate organ functionAdequate performance status defined as Lanksy or Karnofsky performance score ≥50.Subjects of reproductive potential must agree to use acceptable birth control methods.Exclusion Criteria:Active hepatitis B or active hepatitis CHIV infectionActive acute or chronic Graft Vs.
Host Disease requiring systemic therapyConcurrent 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) womenUncontrolled active infection
Source: ClinicalTrials.gov (NCT05674175). StuddyBuddy aggregates publicly available trial information.