Actively Recruiting
Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-17
45
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and efficacy of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 (TRBC1/2 CAR-NK cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL).
CONDITIONS
Official Title
Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide signed informed consent
- Age between 18 and 75 years, any gender
- Diagnosis of relapsed/refractory peripheral T-cell lymphoma with failure of at least 1 prior therapy
- Eligible lymphoma subtypes include Angioimmunoblastic T-cell lymphoma, Anaplastic large cell lymphoma, and PTCL not otherwise specified
- Estimated life expectancy of at least 12 weeks
- Tumor tissue positive for TRBC1/2 (20% or more by immunohistochemistry) or confirmed TCR gene rearrangement by PCR or NGS
- ECOG performance status of 0 to 2
- Adequate organ function including liver enzymes, kidney function, bilirubin levels, heart function, and oxygen saturation as defined
- Blood counts meeting defined thresholds for ANC, platelets, and hemoglobin depending on study phase
- At least 3 months since prior autologous hematopoietic stem cell transplantation
- Prior CAR-NK therapy targeting a different antigen allowed under conditions
- Negative pregnancy test if woman of childbearing potential and agreement to use effective contraception
- At least one measurable lesion
- Completed all prior anti-tumor therapies (including chemotherapy, irradiation, immunotherapy) at least 3 weeks before study drug; 2 weeks washout for non-chemotherapy targeted agents
You will not qualify if you...
- Allergy to any component of the cell product
- History of another cancer not in remission
- Prior allogeneic stem cell or solid organ transplantation
- Received gene therapy within the past 3 months
- Uncontrolled active systemic infection (except simple urinary tract infection or bacterial pharyngitis)
- Active hepatitis B or C infection, syphilis, HIV, or other immunodeficiency diseases
- NYHA Class III or IV heart failure
- Unresolved toxicity from previous anti-tumor therapy above Grade 1 except fatigue, anorexia, and alopecia
- Central nervous system involvement or significant CNS disease
- Prior exposure to agents targeting TRBC1/2
- Lactating women unwilling to stop breastfeeding
- Any condition that increases risk or interferes with study results per investigator
- Positive test for COVID-19 or influenza A virus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Wenbin Qian, professor
CONTACT
X
Xinbin Xiao, Doctor
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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