Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-29
SponsorStephan Grupp MD PhD
About this trial
This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).
Eligibility criteria
Qualifiers
Signed Informed Informed Consent
Disqualifiers
Active hepatitis B or active hepatitis C
HIV infection
Active acute or chronic graft-versus-host disease (GVHD) 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 CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19)
Treatment groups
115 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stephan Grupp MD PhD
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Children's Hospital of Philadelphia
Collaborator
Source ClinicalTrials.gov