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New treatment option for Lymphoma, B-Cell
Official title CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
ClinicalTrials.gov ID: NCT06866873
What this study is testing
What is CAR-T?
CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma, b-cell.
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 study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- people must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the...
- The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
- Age 1-17 years.
- Performance status: people \> 10 years of age: Karnofsky ≥ 50%; people ≤ 10 years of age: Lansky scale ≥ 50%.
- Normal organ function.
You likely can't join if
- Autologous transplant within 6 weeks of planned CAR T cell infusion.
- Recipient of CAR-T cell therapy outside of this protocol.
- Active central nervous system (CNS) or meningeal involvement by tumor.
- History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
- Active human immunodeficiency virus (HIV) infection.
- people with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure...
See the full eligibility criteria
- people must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete...
- The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
- Age 1-17 years.
- Performance status: people \> 10 years of age: Karnofsky ≥ 50%; people ≤ 10 years of age: Lansky scale ≥ 50%.
- Normal organ function.
- Total bilirubin ≤ 3 times upper limit of normal
- AST (SGOT) ≤ 5 times upper limit of normal
- ALT (SGPT) ≤ 5 times upper limit of normal
- Serum Creatinine ≤ 2 times upper limit of normal
- people must have the following hematologic function parameters: Hemoglobin (Hb) level \> 8 g/dL; Absolute Lymphocyte Count \> 0.1x10\^9/L; Platelet \> 50x10\^9/L
- Prior therapy wash-out. At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis.
- people' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document.
- Autologous transplant within 6 weeks of planned CAR T cell infusion.
- Recipient of CAR-T cell therapy outside of this protocol.
- Active central nervous system (CNS) or meningeal involvement by tumor.
- History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
- Active human immunodeficiency virus (HIV) infection.
- people with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or...
- Pregnant or breastfeeding women.
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- Serologic status reflecting active hepatitis B or C infection.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
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, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. 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.