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RECRUITING
NCT06224049
EARLY_PHASE1

Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T

Sponsor: BGI, China

View on ClinicalTrials.gov

Summary

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.

Official title: A Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Targeted Haploidentical Neoantigen T Cell Injection (hNeo-T) in the Treatment of Relapsed or Refractory EBV-positive T-cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2023-12-01

Completion Date

2026-06-30

Last Updated

2024-03-12

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

hNeo-T

After 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.

DRUG

Cyclophosphamide

Chemotherapy preconditioning will be performed before hNeo-T transfusion.

DRUG

Fludarabine

Chemotherapy preconditioning will be performed before hNeo-T transfusion

Locations (1)

ShenZhen University General Hospital

Shenzhen, Guangdong, China