CD22 CAR T-cells for B-cell Acute Lymphoblastic Leukemia after CD19 CAR T-cells
This study is for children, adolescents, and adults aged 3 to 65 who have B-cell acute lymphoblastic leukemia (ALL), a type of blood cancer. You must have already received a CD19 CAR T-cell therapy and currently have no signs of cancer. Researchers want to see if giving a second type of CAR T-cell therapy, called CD22 CAR-transduced T cells, can help keep the cancer from coming back. Before receiving the CD22 CAR T-cells, you will receive two chemotherapy drugs, Cyclophosphamide and Fludarabine. The main goal is to see how many participants remain cancer-free for at least one year after receiving the CD22 CAR T-cells. This study plans to enroll 20 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is designed to see if CD22 CAR T-cell therapy can extend remission in patients who have already received CD19 CAR T-cell therapy.
- What's involved
- Participants will be screened to ensure they meet the study requirements. You will receive chemotherapy (Cyclophosphamide and Fludarabine) followed by the CD22 CAR-transduced T cells.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least one year after receiving the cell infusion to measure how long they remain cancer-free.
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NCT07328503
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
Recruiting
PHASE2Ages 3–65InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~20 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:CD22 CAR-transduced T cellsCyclophosphamideFludarabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1-year RFS (recurrence free survival)
Measured over 1 year post cell infusion
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Sara K Silbert, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Participants must have documentation of pathologic confirmation of a diagnosis of relapsed/refractory B cell acute lymphoblastic leukemia (ALL).
History of CD19 and CD22 expression on malignant cells at diagnosis or relapse.
Age between \>= 3 years and \<= 65 years
Participants must have received an FDA-approved CD19 CAR T-cell construct for treatment of B cell ALL within the time period of \>= 2 months and \<= 7 months prior to apheresis or lymphodepleting (LD) (if apheresis is not done on this protocol).
Must be in an MRD-negative remission as demonstrated by flow cytometry at screening.
Must be ineligible for or unwilling to undergo allogeneic stem cell transplant (SCT).
Clinical performance status (PS): Karnofsky \>= 50% (participants \>= 16 years of age), or Lansky scale \>= 50% (participants \< 16 years of age). Participants who are unable to walk because of paralysis, but who are upright in a wheelchair may be considered eligible.
Must have no ongoing signs of CRS from prior CAR T cell infusion and/or ICANs at screening.
Participants must have adequate organ function as defined below:
Total bilirubin \<= 2 x institutional upper limit of normal (ULN)
Aspartate Aminotransferase (AST) \<= 10 x ULN
Alanine Aminotransferase (ALT) \<= 10 x ULN
creatinine \<= the maximum for age listed below OR measured creatinine clearance \>= 60 mL/min/1.73 m\^2 for participants with
Age: \<=5, Maximum Serum, Creatinine \<= .8 mg/dL
Age: \>5 to \<=10, Maximum Serum, Creatinine \<= 1.0mg/dL
Age: \>10, Maximum Serum, Creatinine \<= 1.2mg/dL
A participant may have continued to expect CAR T cell-associated cytopenias of any grade.
Cardiac function: left ventricular ejection fraction\>= 45% or fractional shortening \>= 28%.
Pulmonary function: baseline oxygen saturation \>= 92% on room air; participants with respiratory symptoms (e.g., dyspnea, hypoxia \<92%) must have a diffusing capacity of the lungs for carbon monoxide (DLCO)/adjusted \> 45%.
Women of childbearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device (IUD), abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.
Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).
Participants must be enrolled on protocol 15-C-0028, Follow-Up Evaluation for Gene- Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.
Ability of participant or /Legally Authorized Representative (LAR) to understand and be willing to sign a written informed consent document.
Exclusion
Any central nervous system (CNS) involvement or signs of non-CNS extramedullary disease.
Any active graft versus host disease (GVHD) in participants who are post-HSCT.
Participants with disease recurrence requiring therapy post CD19 CAR. Note: Maintenance therapy post CD19 CAR (e.g., vincristine or tyrosine kinase inhibitor) for remission maintenance is allowed and will require a 1-week washout prior to apheresis or LD (if apheresis is not done on this protocol).
Any investigational agent within 1 week before apheresis or LD (if apheresis is not done on this protocol).
Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine test performed at screening.
Human immunodeficiency virus (HIV) infection, as measured by seropositivity for (HIV) antibody.
Hepatitis B virus (HBV) infection, as measured by positivity for hepatitis B surface antigen (HBsAg).
Hepatitis C virus (HCV) infection, as measured by seropositivity for hepatitis C.
History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biological composition to any agent used in the study or in the manufacturing of cells.
Uncontrolled, symptomatic intercurrent illness evaluated by medical history, physical exam, and/or laboratory testing, or social situation that would limit compliance with study requirements or would pose an unacceptable risk to the participant.
What this trial measures
- 1-year RFS (recurrence free survival)1 year post cell infusion
RFS of participants will be assessed by a Kaplan-Meier curve. The RFS probability and the median RFS will be reported along with 95% confidence intervals.