Actively Recruiting
Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL
Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2022-11-25
100
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.
CONDITIONS
Official Title
Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma with failure to achieve complete remission or evidence of disease recurrence
- CD7 expression detected in tumor cells by flow cytometry
- Life expectancy greater than 12 weeks
- Karnofsky Performance Status (KPS) or Lansky score of 60 or higher
- Hemoglobin level of 70 g/L or higher (blood transfusion allowed)
- Age between 2 and 70 years
- Blood oxygen saturation of 90% or higher
- Total bilirubin less than or equal to 3 times the upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal
- Informed consent given and signed by patient or guardian
You will not qualify if you...
- History of atrial fibrillation or flutter, recent myocardial infarction within 12 months, prolonged QT syndrome, or significant cardiac dysfunction (LVSF <30% or LVEF <50%)
- Active graft-versus-host disease (GvHD)
- History of severe lung damage
- Presence of advanced malignant tumors with systemic metastasis
- Severe or persistent infections that cannot be controlled
- Severe autoimmune or immunodeficiency diseases
- Active hepatitis B or C infections
- HIV or syphilis infection
- History of serious allergies to biological products including antibiotics
- Clinically significant viral infections or uncontrolled viral reactivation of EBV, CMV, adenovirus, BK virus, or HHV-6
- Symptomatic central nervous system disorders such as uncontrolled epilepsy, stroke, dementia, or cerebellar disease
- Transplant treatment received less than 6 months before enrollment
- Pregnancy, breastfeeding, or pregnancy within the past 12 months
- Any other conditions that researchers believe increase risk or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hebei yanda Hospital
Beijingcun, Hebei, China
Actively Recruiting
Research Team
X
Xian Zhang
CONTACT
J
Jianqiang Li, MD, 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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