Actively Recruiting
CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Led by Zhejiang University · Updated on 2025-08-13
30
Participants Needed
1
Research Sites
208 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/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
CONDITIONS
Official Title
CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or female aged 18 years or older
- Expected survival time longer than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Diagnosed with CD7-positive acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) per NCCN guidelines
- Relapsed or refractory CD7-positive acute leukemia, including no complete remission after standard chemotherapy, remission lasting 12 months or less, no response to remedial treatments, or multiple relapses
- Philadelphia chromosome negative or unable to tolerate tyrosine kinase inhibitor treatment, or Philadelphia chromosome positive unresponsive to tyrosine kinase inhibitors
- Normal lung function with oxygen saturation over 92% without oxygen
- Blood tests showing AST and ALT less than or equal to 2.5 times upper limit of normal (ULN)
- Total bilirubin less than or equal to 1.5 times ULN
- Serum creatinine clearance greater than or equal to 30 mL/min
- Lipase and amylase less than or equal to 2 times ULN
- Fertile men and women of childbearing potential agree to use effective contraception during and for 2 years after treatment
- Negative pregnancy test for women of reproductive age at screening
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- Pregnancy or breastfeeding
- Active infections without cure
- Prolonged QT interval or severe heart disease
- Hypersensitivity or intolerance to any study drug
- Received anticancer chemotherapy or other treatments within 2 weeks before screening
- Previous malignant tumors needing treatment or recurring within 5 years
- Significant central nervous system lesions or involvement including seizures, stroke, dementia, psychosis, or cancerous meningitis
- Terminal organ damage from autoimmune diseases or requiring systemic immunosuppressive treatment within 2 years
- Severe active viral, bacterial, or uncontrolled fungal infections
- Genetic bleeding or coagulation disorders, history of bleeding or blood clots
- Received autologous hematopoietic stem cell transplantation within 8 weeks or plans for it during study
- Participation in other drug clinical trials within 4 weeks or 5 drug half-lives before screening
- Any condition that may increase risk or interfere with study results as judged by researchers
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 medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He 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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