Phase I/II clinical trial of T cell suicide gene therapy following haploidentical stem cell transplantation

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001925-27-GB

Enrollment

Registered

2009-06-10

Start date

2009-10-05

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-versus-host disease (GVHD) resulting from haploidentical bone marrow or blood stem cell transplantation MedDRA version: 9.1 Level: LLT Classification code 10018651 Term: Graft versus host disease

Interventions

Product Name: MSCV-HSVTK/CD34 Murine gamma retrovirus Product Code: MSCV-HSVTK/CD34 Murine gamma retrovirus Pharmaceutical Form: Solution for blood fraction modification Product Name: MSCV-HSVTK/CD34

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with primary immunodeficiencies or haematological malignancies at GOSH (children aged upto 16 years) undergoing haplo identical transplant 2. Both patient and donor must give informed consent in writing. 3. The donor must be willing, able and available for donation of T cells by collection of whole blood or leucapheresis. 4. The patient should be free of serious intercurrent illness. 5. Female patients of child-bearing age must have a negative pregnancy test, and agree to use reliable contraceptive methods for the duration of the therapy. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Donor unfit or unavailable 2. Donor positive for hepatitis b or c, or htlv-1, or hiv 3. Patient receiving Ganciclovir, Aciclovir, Cidofovir a result of active CMV, varicella zoster, adenovirus or herpes simplex infection infection 4. gvhd > grade ii before infusion of gm-t cells 5. serious intercurrent illness 6. Positive pregnancy test or reluctance to use contraception

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Transduction of donor T cells with a retroviral vector encoding a suicide gene/selection marker fusion gene 2. Administration of GM donor T cells to facilitate immune reconstitution following haploidentical HSCT 3. Evaluation of T cell engraftment kinetics and stability 4. Evaluation of immunological and functional potential of GM-T cells 5. Elimination of GM-T cells using Ganciclovir in the event of GVHD 6. Longitudinal evaluation of clinical effect in terms of augmented immune reconstitution, reduced leukaemic relapse, survival and quality of life ;Secondary Objective: ;Primary end point(s): Immunological reconstitution of T-cells after 12 months	—

Measure

Time frame

Main Objective: 1. Transduction of donor T cells with a retroviral vector encoding a suicide gene/selection marker fusion gene 2. Administration of GM donor T cells to facilitate immune reconstitution following haploidentical HSCT 3. Evaluation of T cell engraftment kinetics and stability 4. Evaluation of immunological and functional potential of GM-T cells 5. Elimination of GM-T cells using Ganciclovir in the event of GVHD 6. Longitudinal evaluation of clinical effect in terms of augmented immune reconstitution, reduced leukaemic relapse, survival and quality of life ;Secondary Objective: ;Primary end point(s): Immunological reconstitution of T-cells after 12 months

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026