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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01827579
Acronym
ICAT
Enrollment
37
Registered
2013-04-09
Start date
2014-07-31
Completion date
2020-01-31
Last updated
2022-07-21

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

Conditions

Haematological Malignancies

Keywords

Transplant, CD25/71 allodepleted donor T cells, Infection, Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Adult, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma

Brief 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.

Interventions

BIOLOGICALCD25/71 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

Sponsors

Medical Research Council
CollaboratorOTHER_GOV
University College, London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Circulating CD3+ve T cell count at 4 months post-SCT4 months post transplant

Secondary

MeasureTime frame
Incidence of grade II-IV acute and chronic GVHD1 year post transplant
Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping1 year post transplant
In vitro anti-viral responses of circulating PBMC1 year post transplant
Transplant related mortality at 1 year post-SCT1 year post transplant
Disease-free survival at 1 year post-SCT1 year post transplant

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026