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New treatment option for T Cell Lymphoma
Official title Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells
ClinicalTrials.gov ID: NCT06420076
What this study is testing
What is CD5/CD7 CAR-T?
CD5/CD7 CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t cell lymphoma.
Also referred to as EB-BH2026.
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
- Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc.
- 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 2 to 90
You may be able to join if
- Signed written informed consent; Patients volunteer to participate in the clinical trial;
- Diagnosis is mainly based on the World Health Organization (WHO) 2008;
- Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the...
- Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);
- The expected survival period is greater than 12 weeks;
You likely can't join if
- Patients declining to consent for treatment
- Prior solid organ transplantation
- One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT...
- History of severe pulmonary dysfunction diseases;
- Severe infection or persistent infection cannot be effectively controlled;
- Severe autoimmune disease or congenital immunodeficiency;
See the full eligibility criteria
- Signed written informed consent; Patients volunteer to participate in the clinical trial;
- Diagnosis is mainly based on the World Health Organization (WHO) 2008;
- Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;
- Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);
- The expected survival period is greater than 12 weeks;
- ECOG score ≤2;
- Age 2-60 years old;
- HGB≥70g/L (can be transfused);
- Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.
- Patients declining to consent for treatment
- Prior solid organ transplantation
- One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac...
- History of severe pulmonary dysfunction diseases;
- Severe infection or persistent infection cannot be effectively controlled;
- Severe autoimmune disease or congenital immunodeficiency;
- Active hepatitis;
- Human immunodeficiency virus (HIV) infection;
- Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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, 2 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.