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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
hNeo-T
Biological/VaccineAfter subject screening, peripheral blood mononuclear cell （PBMC） donors matching half or more of the subject's HLA matching will undergo blood collection to prepare hNeo-T. hNeo-T preparation is expected to be 25-30 days after blood collection. In this study, the bridging therapy will be allowed before Chemotherapy preconditioning, and the investigators will decide whether to use it. Chemotherapy preconditioning will be performed before hNeo-T transfusion. If the absolute value of lymphocyte (LYM) before pretreatment is \<0.8×10\^9/L and the subject meets the criteria for cell transfusion, the chemotherapy preconditioning will not be performed and subsequent cell transfusion can be performed directly.
Cyclophosphamide
DrugChemotherapy preconditioning will be performed before hNeo-T transfusion.
Fludarabine
DrugChemotherapy preconditioning will be performed before hNeo-T transfusion
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: hNeo-TExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Safety assessment (Evaluation of treatment-related adverse events according to CTCAEv5.0)
To determine the incidence of AE and SAE in clinical trials
Time frame
The first dose will be administered until 28 days after the last doseSecondary outcomes
1
Objective response rate (ORR)
The total number of subjects with complete response (CR) and partial response (PR) confirmed according to Lugano2014 criteria (i.e., CR+PR) and the proportion of subjects in the corresponding analysis set
Time frame
Up to 48 weeks2
Disease control rate (DCR)
The total number of subjects with CR, PR, and stable disease (SD) confirmed according to Lugano2014 criteria (i.e. CR+PR+SD) and the proportion of subjects in the corresponding analysis set
Time frame
Up to 48 weeks3
Progression free survival (PFS)
According to the Lugano2014 criteria, the time between the start of cell transfusion and the first recorded date of disease progression (PD) or death. If no disease progression is observed, the deletion date should be the date of the last tumor measurement, and if there is no baseline and/or tumor evaluation after transfusion, the PFS will be deleted to the cell transfusion date. Detailed rules on deletion will be described in the statistical analysis plan.
Time frame
Up to 52 weeks4
Duration of response (DOR)
According to the Lugano2014 criteria, the time between a subject's first identification with CR or PR and the first recording of PD or the date of death, depending on which occurs first. For subjects who do not experience disease progression after a combined response, the duration of response will be deleted at the last evaluable tumor measurement date.
Time frame
Up to 36 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
BGI, China
Lead sponsor
Shenzhen University General Hospital
Collaborator
Source ClinicalTrials.gov