Actively Recruiting
Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells
Led by Essen Biotech · Updated on 2024-11-12
60
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the clinical trial
- Diagnosis based on World Health Organization 2008 criteria
- Disease not in complete remission after induction therapy or relapsed after remission
- Leukemic blast cells express CD7 or CD5 (at least 70% positive by testing)
- Expected survival longer than 12 weeks
- ECOG performance status score of 2 or less
- Age between 2 and 60 years old
- Hemoglobin level at least 70 g/L (transfusions allowed)
- Total bilirubin less than 3 times the normal upper limit; AST and ALT less than 5 times the normal upper limit
You will not qualify if you...
- Declining consent for treatment
- Previous solid organ transplant
- Cardiac conditions including atrial fibrillation, recent heart attack, prolonged QT syndrome, significant pericardial effusion, or severe heart failure (NYHA class III or IV)
- Severe lung diseases
- Severe or uncontrolled infections
- Severe autoimmune diseases or congenital immune deficiencies
- Active hepatitis
- HIV infection
- Significant viral infections or uncontrollable viral reactivation including Epstein-Barr virus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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