RecruitingEarly Phase 1NCT06224049

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

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

Sponsor

BGI, China

Enrollment

6 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

T-cell Lymphoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized immune cell therapy (hNeo-T) that targets cancer-specific mutations in patients with a type of T-cell lymphoma (blood cancer) that is associated with the Epstein-Barr virus (EBV) and has returned or not responded to prior treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have T-cell lymphoma confirmed by biopsy - Your tumor has tested positive for the Epstein-Barr virus (EBV) - Your cancer has progressed or not responded after at least one prior treatment regimen - Your tumor tissue sample is available for genetic analysis - Your blood counts, liver, and kidney function are adequate - Your overall health status is acceptable (ECOG 1 or below) **You may NOT be eligible if...** - You have had a prior organ transplant (excluding bone marrow transplant) - Your lymphoma has spread to the brain or spinal cord - You have an active autoimmune disease requiring systemic treatment - You have active HIV, hepatitis B or C, or syphilis infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALhNeo-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.

DRUGCyclophosphamide

Chemotherapy preconditioning will be performed before hNeo-T transfusion.

DRUGFludarabine

Chemotherapy preconditioning will be performed before hNeo-T transfusion

Locations(1)

ShenZhen University General Hospital

Shenzhen, Guangdong, China

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NCT06224049

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