Infusion of Depleted T Cells Following Unrelated Donor Stem Cell Transplant (ICAT)

Haematological Malignancies Clinical Trial

— ICAT  

Official title:

Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827579
• Other study ID #: UCL/11/0519
• Secondary ID: 2013-000872-14MR
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2014
• Est. completion date: January 2020

Study information

• Verified date: July 2022
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether the administration of allodepleted donor T cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age =16 years
• Underlying haematological malignancy
• Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
• Written Informed consent

Exclusion Criteria:

• Life expectancy < 6 weeks
• Female patients who are pregnant and lactating
• Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT

Related Conditions & MeSH terms

• Haematological Malignancies
• Hematologic Neoplasms

Intervention

Biological:
• CD25/71 allodepleted donor T-cells
CD25/71 allodepleted donor T-cells will be administered at a dose of 10^5 /kg at day 30 post-SCT, 3 x 10^5 /kg at day 60 and 10^6 /kg at day 90 post transplant

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating CD3+ve T cell count at 4 months post-SCT		4 months post transplant
Secondary	Incidence of grade II-IV acute and chronic GVHD		1 year post transplant
Secondary	Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping		1 year post transplant
Secondary	In vitro anti-viral responses of circulating PBMC		1 year post transplant
Secondary	Transplant related mortality at 1 year post-SCT		1 year post transplant
Secondary	Disease-free survival at 1 year post-SCT		1 year post transplant