Actively Recruiting
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
Led by Stephan Grupp MD PhD · Updated on 2026-03-27
93
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Stephan Grupp MD PhD
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of giving two CAR T cell therapies, huCART19 and CART22-65s, to children and young adults with advanced B cell Acute Lymphoblastic Leukemia (B-ALL). This condition often returns after initial treatment with CAR T cells, and this study aims to improve outcomes by addressing common reasons for relapse, such as loss of target antigens and immune rejection of earlier treatments. The trial includes patients who have relapsed or are resistant to prior therapies and is led by Stephan Grupp MD PhD. Participants receive two specially designed treatments: CART22-65s, which targets the CD22 antigen to overcome CD19 antigen escape, and huCART19, a humanized version targeting CD19 to reduce immune rejection. The study has two phases; Phase 1 focuses on safely finding a dose level without severe side effects, and Phase 2 expands to evaluate the chosen safe dose in two groups: patients new to CAR T therapy and those previously treated with CAR T cells. During the study, researchers will monitor safety and effectiveness over one year, including tumor response, survival, and persistence of the CAR T cells. Additional assessments include manufacturing feasibility and bioreactivity over five years. Participants will undergo various tests such as flow cytometry to confirm tumor markers, and they must have adequate organ function and performance status. Safety monitoring includes checking for infections and immune-related effects. The total participation time depends on the study phase and follow-up requirements.
CONDITIONS
Brief Title
Co-administration of CART22-65s and huCART19 for B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Patients with documented CD19+ and/or CD22+ Acute Lymphoblastic Leukemia or B Lineage Lymphoblastic Lymphoma
- Cohort A: Patients with relapsed or refractory disease
- Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
- Patients with prior or current Central Nervous System 3 disease if responsive to therapy
- Documentation of CD19 and/or CD22 tumor expression by flow cytometry at last detectable disease
- Age 0 to 29 years
- Adequate organ function
- Performance status score of 50 or above (Lanksy or Karnofsky)
- 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 Vs. Host Disease needing systemic therapy
- Use of systemic steroids or immunosuppression at cell infusion or collection, or likely need for these therapies during collection or after infusion (except physiologic or inhaled steroids)
- Progressive Central Nervous System disease or CNS lesions increasing toxicity risk
- Pregnancy or nursing (lactating)
- Uncontrolled active infection
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.
1 visit (in-person)
Duration - Duration of active treatment period as per protocol
Participants receive co-administration of autologous anti-CD22 CAR T cells (CART22-65s) and humanized anti-CD19 CAR T cells (huCART19) as therapy for relapsed or refractory B-ALL.
Visits as required during treatment for administration and monitoring
Duration - Up to 1 year
Participants are monitored for safety, efficacy, and long-term outcomes after completion of CAR T cell therapy.
Regular follow-up visits over 1 year
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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