Actively Recruiting
A Phase II Study to Examine the Impact of CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Led by National Cancer Institute (NCI) · Updated on 2026-06-08
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new approach for people with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), a type of blood cancer. This study evaluates whether a second CAR T-cell therapy targeting a protein called CD22 can extend remission after initial treatment with CD19 CAR T-cell therapy. The trial focuses on participants aged 3 to 65 years who have no detectable cancer following prior CD19 CAR T-cell treatment. Participants will undergo screening including imaging scans, heart function tests, bone marrow biopsy, and spinal fluid collection. Their immune cells (T cells) will be collected through a procedure called leukapheresis, then modified in a lab to create the CD22 CAR T-cell therapy. Before receiving the modified cells through a vein, participants will take chemotherapy drugs for four days to prepare their body. Some participants may need hospital stays during treatment. After treatment, participants will have follow-up visits for two years to monitor safety, treatment effects, and disease status. Researchers will assess relapse-free survival at one year as the primary outcome and also evaluate longer-term survival and safety. Various tests and biological assessments will be conducted throughout the study to understand how well the CAR T-cells persist and function over time.
CONDITIONS
Brief Title
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia confirmed by pathology
- History of CD19 and CD22 expression on cancer cells
- Age between 3 and 65 years
- Received FDA-approved CD19 CAR T-cell therapy 2 to 7 months before leukapheresis or lymphodepleting treatment
- Currently in minimal residual disease (MRD)-negative remission by flow cytometry
- Ineligible for or unwilling to have an allogeneic stem cell transplant
- Karnofsky or Lansky performance status of 50% or higher
- No ongoing cytokine release syndrome or neurotoxicity from prior CAR T-cell treatment
- Adequate organ function including liver, kidney, heart, and lung measures
- Women of childbearing potential must agree to use effective contraception for up to 12 months after treatment
- Men able to father children must agree to use contraception for up to 7 months after treatment
- Willingness to discontinue nursing during and for 6 months after treatment
- Enrollment in a follow-up protocol for gene therapy-related adverse events
- Ability to understand and sign informed consent
You will not qualify if you...
- Involvement of central nervous system or non-CNS extramedullary disease
- Active graft versus host disease after stem cell transplant
- Disease recurrence requiring therapy after CD19 CAR T-cell treatment (maintenance therapy allowed with washout)
- Use of investigational agents within 1 week before leukapheresis or lymphodepleting treatment
- Pregnancy confirmed by testing
- Infection with HIV, hepatitis B, or hepatitis C
- History of severe allergic reaction to study agents or related compounds
- Uncontrolled illness or social situations that limit study compliance or increase risk
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 - 4 days
Participants receive a 4-day lymphodepleting chemotherapy regimen including fludarabine and cyclophosphamide before receiving CD22 CAR T-cells.
Daily visits for 4 days (in-person)
Duration - 1 day
Participants receive CD22 CAR T-cells infusion following the preparative regimen to extend remission.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are monitored for toxicity, antitumor effects, CAR expansion and persistence, and other biological correlatives for up to 2 years after cell infusion.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Pediatric Leukemia, Lymphoma Transpl
S
Sara K Silbert, M.D.
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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