Actively Recruiting
CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia
Led by Zhejiang University · Updated on 2024-10-09
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia
CONDITIONS
Official Title
CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with severe aplastic anemia based on Chinese expert consensus (2017) including low bone marrow proliferation and pancytopenia
- Have a suitable related donor for allogeneic hematopoietic stem cell transplantation with at least haploidentical match
- Not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation
- Creatinine clearance greater than 60 ml/min
- Liver function within specified limits: total bilirubin ≤1.5 times upper normal limit; ALT and AST ≤3 times upper normal limit (or higher limits if liver invasion present)
- Left ventricular ejection fraction (LVEF) ≥50%
- No active infection in lungs and blood oxygen saturation on room air ≥92%
- Estimated survival time of at least 3 months
- ECOG performance status of 0 to 1
- Agree to use effective contraception before, during, and for 6 months after study participation
- Voluntarily consent to participate in the trial
You will not qualify if you...
- Allergy to pre-treatment medications
- Active acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening
- Received systemic drug therapy for GvHD within 4 weeks before reinfusion
- History of epilepsy or central nervous system disorders
- Electrocardiogram showing prolonged QT interval or severe heart diseases such as severe arrhythmia
- Less than 100 days since previous allogeneic hematopoietic stem cell transplantation
- HIV infection or active hepatitis B or C virus infection or uncured active infection
- Low proliferation response to CD3/CD28 co-stimulation signal (less than 5 times)
- Received anti-cancer chemotherapy or other drug treatment within 2 weeks before screening
- Any condition judged by investigators to increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Z Huang, MD
CONTACT
Y
Yongxian Hu, MD
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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