Actively Recruiting
CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study
Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2023-11-18
9
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.
CONDITIONS
Official Title
CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with relapsed or refractory T-lymphoblastic lymphoma or T-cell acute lymphoblastic leukemia as per WHO classification
- Relapse defined by >5% primordial cells in blood or bone marrow after remission, with early or late recurrence or post-transplant relapse
- Refractory patients who failed at least two courses of standard induction chemotherapy or salvage treatment
- Tumor cells must be CD7 positive by bone marrow flow cytometry or pathological testing
- If tumor cells are in peripheral blood, they must be CD4 and CD8 double negative
- Life expectancy greater than 12 weeks
- ECOG performance status 0 to 2
- Hemoglobin at least 70 g/L and platelet count at least 50 x 10^9/L (transfusion allowed)
- Adequate liver, kidney, and cardiopulmonary function meeting specified criteria (oxygen saturation ≥92%, LVEF ≥50%, bilirubin <3x ULN, ALT/AST <3x ULN, creatinine <1.5x ULN or clearance >50 ml/min)
- Able to provide informed consent
You will not qualify if you...
- NYHA class III or higher heart failure, recent serious heart events, or QTc interval >480 ms
- Within 6 months of allogeneic hematopoietic stem cell transplantation
- Active graft-versus-host disease or requiring immunosuppressive therapy
- Other malignancies within 5 years except certain treated cancers
- History of serious central nervous system diseases
- Active or uncontrolled infections requiring systemic treatment within 7 days
- Autoimmune diseases requiring immunosuppressive treatment in past 2 years
- Positive tests for active hepatitis B, hepatitis C, HIV, CMV, or syphilis infection
- Participation in other clinical trials within 4 weeks or recent drug half-life overlap
- Severe allergy to biological products
- Unstable severe liver, kidney, or metabolic diseases needing drug therapy
- Pregnant or breastfeeding women or planning pregnancy within 2 years
- Prior CAR-T or gene-modified cell therapy
- Any condition increasing risk or interfering with study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
W
Weili Zhao, Dr
CONTACT
L
Liang Huang, Dr
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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