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New treatment option for Acute Lymphoblastic Leukemia
Official 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
ClinicalTrials.gov ID: NCT07328503
What this study is testing
What is CD22 CAR-transduced T cells?
CD22 CAR-transduced T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Acute lymphoblastic leukemia (ALL) is a type of blood cancer. Chimeric antigen receptor (CAR) therapy involves taking immune cells (T cells) from a person and modifying them to better target cancer cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 65
You may be able to join if
- 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 \<=...
- Must be in an MRD-negative remission as demonstrated by flow cytometry at screening.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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 \ = 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 \ 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.