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Immunotherapy With Tacrolimus Resistant EBV CTL for Lymphoproliferative Disease After Solid Organ Transplant

NCT03131934 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-05-17

No results posted yet for this study

Summary

This is an open label, non-randomised, multicentre Phase I to determine the safety of tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (EBV CTL) and compare their expansion/persistence with control EBV CTL in solid organ transplant patients with post-transplant lymphoproliferative disease (PTLD). Each patient will receive an infusion of two ATIMPs - autologous EBV CTL retrovirally transduced with (a) a calcineurin mutant (CNA12) that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8).

Conditions

  • Post-transplant Lymphoproliferative Disease
  • Transplant-Related Hematologic Malignancy

Interventions

BIOLOGICAL

Autologous EBV-CTL transduced with vector SFG-CNA12

Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the retroviral vector SFG-CNA12 conferring resistance to tacrolimus

BIOLOGICAL

Autologous EBV-CTL transduced with control vector SFG-CNA8

Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the control retroviral vector SFG-CNA8

PROCEDURE

Leucapheresis

Patients will undergo an unstimulated leucapheresis to isolate the required immune cells to produce the EBV-CTLs

Sponsors & Collaborators

  • Genetix Biotherapeutics Inc.

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Principal Investigators

  • Prof. Persis Amrolia · Great Ormond Street Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2020-06-30
Completion
2025-05-15

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131934 on ClinicalTrials.gov