Actively Recruiting
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
Led by Stephan Grupp MD PhD · Updated on 2025-12-26
89
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
S
Stephan Grupp MD PhD
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosis of CD19-positive Acute Lymphoblastic Leukemia (ALL) or B Lineage Lymphoblastic Lymphoma (Lly)
- For Cohort A: Relapsed or refractory ALL or Lly without prior CAR T-cell therapy meeting specific relapse or treatment failure criteria
- For Cohort B: Poor response to prior B cell directed engineered cell therapy as defined by partial or no response, CD19+ relapse, or early B cell recovery
- Prior or current CNS3 disease eligible if responsive to therapy
- Documentation of CD19 expression in bone marrow, blood, cerebrospinal fluid, or tumor tissue
- Age 0 to 29 years
- Adequate organ function including kidney, liver, lung, and heart function
- Performance status with Lanksy or Karnofsky score of 50 or higher
- Agreement to use acceptable birth control methods if of reproductive potential
You will not qualify if you...
- Active hepatitis B or hepatitis C infection
- HIV infection
- Active acute or chronic graft-versus-host disease requiring systemic therapy
- Use of systemic steroids or immunosuppression at time of cell infusion or collection, unless for disease treatment at other times or physiologic replacement
- Progressive CNS disease or CNS parenchymal lesions increasing risk of toxicity
- Pregnancy or nursing
- Uncontrolled active infection
- History of seizure disorder requiring ongoing anti-epileptic therapy
- Previous CAR T cell therapy with history of grade 3 or higher ICANS adverse event
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
CART Nurse Navigator
CONTACT
M
Melissa S Varghese, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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