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Co-administration of CART22-65s and huCART19 for B-ALL
RecruitingPhase 1/2
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
Who can join
Up to age 29 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Signed informed consent form 2. Patients with documented CD19+ and/or CD22+ ALL/LLy: 1. Cohort A: Patients with relapsed or refractory ALL/LLy: 2. Cohort B: Patients with poor response to prior B cell directed engineered cell therapy 3. Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy 4. 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. 5. Age 0-29 years 6. Adequate organ function 7. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50. 8. Subjects of reproductive potential must agree to use acceptable birth control methods. Exclusion Criteria: 1. Active hepatitis B or active hepatitis C 2. HIV infection 3. Active acute or chronic Graft Vs. Host Disease requiring systemic therapy 4. 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. 5. 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. 6. Pregnant or nursing (lactating) women 7. Uncontrolled active infection
About the study
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).
What is being tested
- Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s) (biological)
- Autologous, humanized anti-CD19 CAR T cell therapy (huCART19) (biological)
Sponsor: Stephan Grupp MD PhD · Participants: 93 · Started: Jan 25, 2023
Contact the study team
- CART Nurse Navigator · Phone: 445-942-5891
- Melissa S. Varghese, M.S. · Phone: 8455535358
Official record on ClinicalTrials.gov — NCT05674175
Locations in the U.S.
| Pennsylvania | Children's Hospital of Philadelphia, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.