Actively Recruiting
Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T
Led by BGI, China · Updated on 2024-03-12
6
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
B
BGI, China
Lead Sponsor
S
Shenzhen University General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Objective: To evaluate the safety and tolerability of hNeo-T injection in patients with relapsed or refractory EBV-positive T-cell lymphoma. Secondary objective: To evaluate the effectiveness of hNeo-T injection, and to evaluate the objective response rate (ORR) and disease control rate (DCR) by Lugano2014 criteria; Progression-free survival (PFS), duration of response (DOR), and overall survival (OS ) followed. Objective of the exploratory study: To investigate the in vivo process of hNeo-T injection and describe the activity and related biological functions of hNeo-T cells in vivo, including but not limited to.
CONDITIONS
Official Title
Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Histologically or cytologically confirmed T-cell lymphoma with at least one measurable tumor lesion
- HLA type includes HLA-A0201, 1101, 2402, or 0203 with at least one healthy donor partially matching
- EBV positive status confirmed before or after testing
- Available tumor tissue for gene sequencing and neoantigen screening within 2.5 years
- Disease progression after adequate first-line systemic treatment or no remission after multiple treatment cycles
- Willingness to participate and sign informed consent
- ECOG performance status of 1 or less
- Venous access suitable for blood collection
- Expected survival time of at least 6 months
- Willing to use contraception and negative pregnancy test for women of childbearing potential
- Adequate laboratory results and organ function as specified
- Completed required washout periods from prior therapies and recovered from major surgery adverse effects
You will not qualify if you...
- Pregnant or breastfeeding women
- History of severe allergic reactions to study cells or drugs
- History of organ transplantation except hematopoietic stem cell transplant
- History of allogeneic hematopoietic stem cell transplantation or graft-versus-host disease
- Lymphoma involvement of the central nervous system
- Active or certain past autoimmune diseases deemed ineligible
- Uncontrolled infections or serious concomitant diseases
- Severe liver or kidney impairment, uncontrolled diabetes, lung disease, hypertension, or significant cardiovascular/cerebrovascular conditions
- Scheduled use of high-dose glucocorticoids or immunosuppressants prior to or during study
- Scheduled use of immunomodulatory drugs within 2 weeks before preconditioning or during study
- Inability or unwillingness to comply with study requirements
- Genetic defects affecting antigen presentation or cell killing
- History of other cancers within 5 years except certain curable or in situ cancers
- Any medical condition that may interfere with safety or efficacy evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ShenZhen University General Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
LiXin Wang, 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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