Actively Recruiting
Phase 1/2b Trial of Autologous Humanized CD19-Directed CAR T-Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B Cell Acute Lymphoblastic Leukemia
Led by Stephan Grupp MD PhD · Updated on 2026-05-26
115
Participants Needed
1
Research Sites
104 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
Researchers are evaluating a new manufacturing process using the CliniMACS Prodigy platform to produce humanized CD19-directed CAR T cells (huCART19) for children and young adults with B cell Acute Lymphoblastic Leukemia (B-ALL), including those with relapsed or refractory disease. This trial aims to determine the safety and effectiveness of this second-generation, semi-automated manufacturing process, which may reduce the time and resources needed compared to the first-generation method. The study includes a phase 1 dose escalation portion using a "3+3" design to find the recommended dose of huCART19 cells for patients previously treated with CD19-directed CAR T cells. Two dose escalations are planned. If safe doses are identified, a phase 2b dose expansion phase will open, enrolling participants in two groups: those who have not received CAR T-cell therapy before and those with prior CD19-directed CAR T cell treatment. Participants receive autologous T cells engineered to target CD19 on leukemia cells. Participants will be closely monitored for safety and treatment response over a 5-year period. Researchers will assess safety, efficacy, manufacturing feasibility, and anti-tumor response through various tests and evaluations. Key outcomes include remission rates, CAR T cell persistence, event-free and overall survival. The study involves regular clinical assessments and laboratory monitoring to track these outcomes throughout the trial duration.
CONDITIONS
Brief 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
- Documented CD19-positive Acute Lymphoblastic Leukemia or B Lineage Lymphoblastic Lymphoma
- For Cohort A: relapsed or refractory disease without prior CAR T-cell therapy, including specific relapse or refractory conditions
- For Cohort B: poor response or CD19-positive relapse after prior CAR T-cell therapy
- Responsive CNS disease if previously present
- Documented CD19 expression in tumor tissue or blood
- Age between 0 and 29 years
- Adequate organ function including kidney, liver, lung, and heart function
- Performance status score of 50 or higher
- Agreement to use birth control if of reproductive potential
You will not qualify if you...
- Active hepatitis B or C infection
- HIV infection
- Active graft-versus-host disease requiring systemic treatment
- Use of systemic steroids or immunosuppression during cell infusion or collection except for allowed therapies
- Progressive CNS disease or CNS lesions increasing risk
- Pregnancy or nursing
- Uncontrolled active infection
- History of seizure disorder requiring ongoing anti-epileptic treatment
- History of severe neurotoxicity (grade 3 or higher ICANS) after previous CAR T therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to several weeks including dose escalation and dose expansion phases
Participants receive autologous humanized CD19-directed CAR T-cell therapy (huCART19) manufactured using the CliniMACS Prodigy platform to treat pediatric B cell Acute Lymphoblastic Leukemia.
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
M
Melissa S Varghese, M.S.
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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