Co-administration of CART22-65s and huCART19 for B-ALL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 29
SponsorStephan Grupp MD PhD
About this trial
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
Qualifiers
Signed informed consent form
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s)
- Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)
Treatment groups
93 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stephan Grupp MD PhD
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov