CMV TCR Gene Therapy Trial

Phase 1

• Conditions: CMV reactivation/infection in post allogeneic haematopoietic stem cell transplant recipients. Allo-HSCT being performed for underlying haematological malignancy (eg, AML, ALL, NHL, Hodgkin Lymphoma, etc).; MedDRA version: 19.0Level: LLTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2008-006649-18-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-22
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Inclusion Criteria (Recipient):
1. Age: 18-65 years (inclusive)
2. Recipients of HLA-matched sibling Allo-HSCT for underlying haematological malignancies as per national and institutional guidelines.
3. HLA-A*0201 positive
4. CMV seropositive (anti-CMV IgG detectable pre-transplant)
5. Meets all other recipient criteria for Allo-HSCT as per institutional guidelines.

Inclusion Criteria (Donors)
1. Pre-selected HLA-matched sibling stem cell donor (as per institutional criteria)
2. Age: 16 years or older (inclusive)
3. HLA-A*0201 positive
4. CMV seronegative (no anti-CMV IgG detectable)

For further details of inclusion and exclusion criteria please see Clinical Trial Protocol.

Patients will be recruited to the study during their pre-transplant consultation and medical. Participants will only be eligible for the study if they are: (i) HLA-A*0201 positive (the TCR is HLA-A*0201 restricted and CMV pp65-specific) and (ii) CMV seropositive (CMV IgG detected) and their donor is: (i) an HLA-matched sibling/family member and (ii) CMV seronegative (CMV IgG not detected). All participants will be required to give signed, informed consent. A detailed explanation of the study rationale and risks will be given by the relevant PI. All patients will receive a patient information sheet and be given time to discuss the study with family and friends.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

(i) Pregnant or lactating women
(ii) Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
(iii) HIV infection

And to be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
(i) Active acute GVHD > Grade I
(ii) Concurrent use of systemic corticosteroids
(iii) Organ dysfunction as measured by
ii.creatinine > 200 uM/l
iii.bilirubin > 50 uM/l
iv.ALT > 3x upper limit of normal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified