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New treatment option for Leukemia, B-Cell
Official title Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
ClinicalTrials.gov ID: NCT05010564
What this study is testing
What is Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy?
Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for leukemia, b-cell.
Also referred to as Cytoxan, Fludara.
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
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 25
You may be able to join if
- FOR PROCUREMENT:
- Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22
- Age between 1 and 25 years.
- Life expectancy of ≥ 8 weeks
- Weight ≥ 10 kg
You likely can't join if
- FOR PROCUREMENT:
- Active malignancy other than disease under study
- Presence of active severe infection, defined as: a) positive blood culture within 48 hours of collection, OR; b) known history of active viral...
- Primary immunodeficiency syndrome
- Pregnant or breastfeeding
- Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol...
See the full eligibility criteria
- FOR PROCUREMENT:
- Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22
- Age between 1 and 25 years.
- Life expectancy of ≥ 8 weeks
- Weight ≥ 10 kg
- people ≥ 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian's consent must be obtained for people \< 18 years of age...
- The subject must discontinue all anti-cancer agents and, in the opinion of the investigator, has recovered from significant acute toxic effects of: a) Chemotherapy and biologic agents: All chemotherapy and biologic...
- FOR PROCUREMENT:
- Active malignancy other than disease under study
- Presence of active severe infection, defined as: a) positive blood culture within 48 hours of collection, OR; b) known history of active viral infections including infection with HIV, hepatitis B, hepatitis C or HTLV
- Primary immunodeficiency syndrome
- Pregnant or breastfeeding
- Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol INCLUSION CRITERIA FOR T-CELL THERAPY
- Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22 and meeting any of the following conditions:
- B-ALL with no prior history of allo-HCT with one of the following:
- Second or subsequent marrow relapse
- First marrow relapse if, at the end of re-induction, bone marrow showing ≥ 0.01% blasts by morphology \&/or flow cytometry
- Primary refractory disease defined by having ≥ 5% blasts in the marrow by morphology and/or minimal residual (MRD) testing after 2 or more separate induction regimens (which may include CD19-targeting therapies)
- Subject has an indication for allo-HCT but deemed ineligible (including people who have persistent MRD prior to allo-HCT)
- CD19(+) or CD19(-) relapse or refractory ALL after infusion of CD19- CAR-T cells or other CD19-targeting immunotherapies. CD20 or CD22 expression is required for CD19(-) B-ALL. Or
- B-ALL recurrent after allo-HCT defined as having ≥ 0.01% marrow disease
- Available transduced T-cells with ≥ 15% expression of CD19, CD20 or CD22 CAR by flow cytometry.
- Prohibited medications - washout periods (prior to CAR-T cell product infusion): Radiation therapy including TBI and cranial radiation. Local/palliative radiation excluded: ≥ 4 weeks. Cytotoxic chemotherapy: ≥ 2 days...
- Total Bilirubin: ≤ 3X upper limit of normal (ULN) for age OR conjugated bilirubin ≤ 2mg/dl, except in people 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 (as indicated below) or Creatinine clearance or GFR (as measured or estimated by Cockcroft Gaultor Schwartz) ≥ 50 mL/min/1.73m2...
- Pulse oximetry of ≥ 90% on room air
- 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).
- Lansky score of ≥ 50% (age ≥1 and \< 16 years) or Karnofsky score of ≥ 50% (age ≥ 16 years). Refer to appendix IV
- Donor lymphocyte infusions (DLI) completed \> 6 weeks prior to CAR-T cell infusion
- people of childbearing/fathering potential must agree to use highly effective contraception (see Appendix IIII for acceptable forms of contraception) from the time of initial T cell infusion through 12 months following...
- people \> 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian's consent must be obtained for people \< 18 years of age...
- Pregnant or lactating
- Presence of any condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy.
- If history of allogeneic Hematopoietic Cell transplantation (allo-HCT):
- active GVHD: acute GVHD \>/= Grade 2 or chronic GVHD, extensive global severity score, OR
- actively taking corticosteroids for management of GVHD at a dose of \> 0.5 mg/kg/day of prednisone equivalent
- receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to T-cell infusion.
- Acute symptomatic CNS pathology requiring active medical intervention, including paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 12 months to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.