EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma

Conditions

• EBV Related Non-Hodgkin's Lymphoma
• EBV-Related Hodgkin Lymphoma
• EBV-Related Lymphoproliferative Disorder

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Dose Level 1A: 2 x 10^7 cells/m2 — BIOLOGICAL
  2 x 10\^7 cells/m2
• Dose Level 2A: 6 x 10^7 cells/m2 — BIOLOGICAL
  6 x 10\^7 cells/m2
• Dose Level 2B: 6 x 10^7 cells/m2 — BIOLOGICAL
  6 x 10\^7 cells/m2
• Dose Level 3B: 2 x 10^8 cells/m2 — BIOLOGICAL
  2 x 10\^8 cells/m2
• Dose Level 3A: 2 x 10^8 cells/m2 — BIOLOGICAL
  2 x 10\^8 cells/m2

Study Details

This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases. Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses. The investigators think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body. The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer.

Key Dates

Start date

Oct 31, 2022

Status verified

Nov 2025

Primary completion

Apr 1, 2026

Completion

Mar 30, 2039

Study Design

Enrollment

52 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Treatment without lymphodepletion chemotherapy
  C7R-EBVSTs Group B will be activated if only limited expansion and clinical efficacy is observed in Group A
• Experimental: Arm B: Treatment with lymphodepletion chemotherapy
  C7R-EBVSTs with lymphodepletion chemotherapy

Primary Outcome Measure

1. Dose limiting toxicity rate (DLT) by Common Terminology Criteria for Adverse Events v5.0 [ Time Frame: 28 days post infusion ]

Central Contacts

• Bilal Omer, MD
  832-824-6855
  [email protected]
• Dustin McFadden
  832-824-3855
  [email protected]

Locations (2)

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