Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T
ConditionT-cell Lymphoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBGI, China
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years old, and ≤75 years old, gender is not limited;
Must have histologically or cytologically confirmed T-cell lymphoma with at least one measurable tumor lesion (according to Lugano2014 criteria);
The subject's HLA type is HLA-A0201/1101/2402/0203 (containing at least one of the subtypes, as determined by the test report issued by the central laboratory), and there is at least one healthy donor who is a semi-matching HLA type or more with the subject. At least one of the HLA matching loci is HLA-A0201/1101/2402/0203；
The subject has been previously determined to be EBV positive or has been determined to be EBV positive after testing;
Disqualifiers
Pregnant or lactating women;
People with a history of severe hypersensitivity to the cells used in this study and to any drugs;
Patients with a history of organ transplantation, excluding hematopoietic stem cell transplantation;
History of allogeneic hematopoietic stem cell transplantation; Acute or chronic graft-versus-host disease (GVHD);
Trial design
Treatments tested in this trial
- hNeo-T
- Cyclophosphamide
- Fludarabine
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
BGI, China
Lead sponsor
Shenzhen University General Hospital
Collaborator
Source ClinicalTrials.gov