New CAR T-Cell booster aims to stop leukemia relapse
NCT ID NCT07328503
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This study tests whether a second type of CAR T-cell therapy, targeting CD22, can extend remission in people with B-cell acute lymphoblastic leukemia who have no signs of cancer after initial CD19 CAR T-cell treatment. About 20 children, adolescents, and adults will receive the modified cells after a short chemotherapy prep. The goal is to see if this approach can prevent the cancer from coming back for at least a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD22 CAR T-cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could help keep leukemia in remission longer for patients who have already received CD19 CAR T-cell therapy.
- What could go wrong
- This is a small, early-phase trial with only 20 participants. The cancer may still return, and the treatment carries risks like severe immune reactions or organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * 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 creatinine levels above the max * 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. Note: WOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 7 months after the last dose of study drugs. We also will recommend men ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period. * 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 CRITERIA: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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