Actively Recruiting
CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-30
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CD70 is a promising target for immunotherapy because it is overexpressed in T-cell lymphoma (TCL) and acute myeloid leukemia (AML) tumor cells but is found in deficient levels in normal tissues and hematopoietic stem cells. This study aims to evaluate the safety and efficacy of CD70-targeted CAR-NK (CD70-CAR-NK) cells in patients with relapsed and refractory TCL and AML.
CONDITIONS
Official Title
CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory T-cell lymphoma or acute myeloid leukemia according to WHO classification
- Age between 18 and 75 years, any gender
- Relapsed/refractory T-cell lymphoma after at least two prior treatments (including resistance to Brentuximab vedotin for anaplastic large-cell lymphoma)
- Relapsed/refractory AML defined by specific criteria including blasts ≥ 5%, relapse after remission, or failure to respond to standard regimens
- Expected survival of at least 12 weeks
- Positive CD70 expression in tumor tissue with ≥ 20% positive cells
- ECOG performance status 0 to 2
- Adequate organ function including specified liver enzymes, kidney function, cardiac ejection fraction ≥ 45%, oxygen saturation > 92%, and blood counts
- Previous autologous hematopoietic stem cell transplantation allowed once
- Prior CAR-T therapy allowed if ineffective or relapsed after complete remission
- Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception
- No active lung infection and oxygen saturation ≥ 92%
- Completed other anti-tumor treatments at least 3 weeks prior (2 weeks for targeted drugs without chemotherapy)
- Two negative tests for COVID-19 or influenza A
You will not qualify if you...
- History of allergy to components of the cellular product
- History of other tumors
- Grade II-IV acute graft-versus-host disease or extensive chronic GVHD after allogeneic stem cell transplantation or ongoing anti-GVHD treatment
- Gene therapy within the past 3 months
- Active infections requiring treatment except simple urinary tract infections or bacterial pharyngitis
- Hepatitis B or C virus infection, syphilis, AIDS, or other immunodeficiency diseases
- Grade III or IV cardiac insufficiency
- Unresolved toxicities from previous anti-tumor treatments (except fatigue, anorexia, alopecia)
- History of epilepsy or other central nervous system diseases
- Lactating women unwilling to stop breastfeeding
- Any condition increasing risk or interfering with study results as judged by the investigator
- Positive nucleic acid tests for COVID-19 or influenza A
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
W
Wenbin Qian
CONTACT
Y
Yang Xu, Ph.D
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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