OncoMatch/Clinical Trials/NCT05010564
Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
Is NCT05010564 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for leukemia, b-cell.
This is a gene transfer study for patients with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL) that has come back or has not gone away after treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. For example, T lymphocytes can kill cancer cells but there normally are not enough of them to kill all the cancer cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study targets CD19, CD20 and CD22. This antibody sticks to ALL cells because of a substance on the outside of these cells called CD19, CD20 and/or CD22. For this study, the antibody to CD19, CD20 and CD22 has been changed so that instead of floating free in the blood, it is now joined to the T cells. When T-cells contain an antibody that is joined to them, they are called chimeric antigen receptor- T cells or CAR-T cells. In the laboratory, we have also found that T cells work better if we also add proteins that stimulate them. One such protein is called 4-1BB. Adding the 4-1BB molecule makes the cells grow better and last longer in the body, giving them a better chance of killing the leukemia cells. In this study we are going to attach the CD19/CD20/CD22 chimeric receptor that has 4-1BB added to the patient's T cells. We will then test how long the cells last. These T cells, called "TRICAR-ALL" T cells are investigational products not approved by the Food and Drug Administration (FDA) outside the context of a clinical trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression
expression of CD19, CD20 and/or CD22
Required: CD20 expression
expression of CD19, CD20 and/or CD22
Required: CD22 expression
expression of CD19, CD20 and/or CD22
Prior therapy
Cannot have received: CAR-T cell therapy
Exception: must be at least 30 days from most recent CAR-T cell infusion prior to collection
Prior CAR-T cell therapy: must be at least 30 days from most recent CAR-T cell infusion prior to collection
Cannot have received: Antithymocyte globulin (ATG) formulations
Exception: No antibodies within three (3) half-lives prior to collection (or within 4 weeks) whichever is shorter
Immunotherapy directed at leukemia: No antibodies within three (3) half-lives prior to collection (or within 4 weeks) whichever is shorter. This includes Antithymocyte globulin (ATG) formulations
Cannot have received: Anti T-cell Antibodies, Alemtuzumab (Alemtuzumab)
Exception: must be discontinued ≥ 8 weeks prior to collection
Anti T-cell Antibodies, Alemtuzumab: must be discontinued ≥ 8 weeks prior to collection
Lab requirements
Kidney function
Adequate renal function defined as serum creatinine that is ≤ maximum based on age/gender or Creatinine clearance or GFR ≥ 50 mL/min/1.73m2
Liver function
Total Bilirubin: ≤ 3X upper limit of normal (ULN) for age OR conjugated bilirubin ≤ 2mg/dl, except in subjects with Gilbert's syndrome where a total bilirubin level of up to 5.3 mg/dL will be acceptable; ALT ≤ 5 times upper limit of normal
Cardiac function
Left ventricular fractional shortening (LVFS) ≥ 28% confirmed by echocardiogram or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram (MUGA or MRI heart may replace echocardiogram)
Total Bilirubin: ≤ 3X upper limit of normal (ULN) for age OR conjugated bilirubin ≤ 2mg/dl, except in subjects with Gilbert's syndrome where a total bilirubin level of up to 5.3 mg/dL will be acceptable; ALT ≤ 5 times upper limit of normal; Adequate renal function defined as serum creatinine that is ≤ maximum based on age/gender or Creatinine clearance or GFR ≥ 50 mL/min/1.73m2; Left ventricular fractional shortening (LVFS) ≥ 28% confirmed by echocardiogram or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram (MUGA or MRI heart may replace echocardiogram)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Texas Children's Hospital · Houston, Texas
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