Actively Recruiting
Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
Led by Stanford University · Updated on 2026-02-10
20
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.
CONDITIONS
Official Title
Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory B cell acute lymphoblastic leukemia (ALL)
- Eligible to receive commercial KYMRIAH® (tisagenlecleucel) as per FDA approved guidelines
- Demonstrated CD19 and CD22 expression on malignant cells by immunohistochemistry or flow cytometry
- Age between 1 year and 25 years 364 days at enrollment
- Karnofsky performance status ≥ 50% for participants over 16 years; Lansky scale ≥ 50% for participants 16 years or younger
- Normal organ and marrow function including ANC ≥ 750/uL, platelet count ≥ 50,000/uL, ALC > 150/uL, adequate kidney, liver, lung, and heart function
- Participants with CNS involvement or history of CNS involvement eligible if no neurological symptoms interfering with toxicity assessment
- Participants with prior autologous SCT with disease progression or relapse eligible; allogeneic SCT recipients must be at least 100 days post-SCT, no graft versus host disease, and off immunosuppressive agents for at least 30 days
- Females of childbearing potential and males with fertility potential must agree to use birth control during and for 4 months after chemotherapy or while CAR T cells are detectable
- Females of childbearing potential must have a negative pregnancy test
- Must meet washout periods since prior therapies according to commercial KYMRIAH® SOPs
- Must have recovered from acute side effects of prior therapy to meet eligibility
- If prior CAR therapy, must be at least 30 days since prior therapy before apheresis
- Ability to give informed consent; parental or guardian consent required for participants under 18, with assent as appropriate
You will not qualify if you...
- Presence of HIV, Hepatitis B, or Hepatitis C infection or uncontrolled symptomatic illness
- Hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressing disease that would prevent study completion
- Severe immediate hypersensitivity reaction to related compounds
- Active CNS disorder or recent history (within 12 months) of myocardial infarction, cardiac procedures, unstable angina, or significant cardiac disease
- Primary immunodeficiency or autoimmune disease requiring systemic immunosuppression or disease-modifying agents within the last 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
M
Michelle Fujimoto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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