Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2022-07-14
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Expanded autologous T regulatory cells
This is an open-label, non-randomised interventional trial.
Expanded autologous T regulatory cells
A 3+3 dose escalation design with expanded T regulatory cells administered on Day 1 and Day 15
Interventions
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Expanded autologous T regulatory cells
A 3+3 dose escalation design with expanded T regulatory cells administered on Day 1 and Day 15
Eligibility Criteria
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Inclusion Criteria
* No evidence of constitutional/inherited AA based on clinical findings, absence of family history of AA, normal DEB test and normal Kings bone marrow failure gene panel
* Very severe, severe or non-severe AA
* Lack a matched sibling donor (MSD) or matched unrelated donor (MUD), or ineligible for MSD/MUD HSCT
* Transfusion dependent
* Failed or ineligible for a course of ATG and CSA
* Failed / intolerant or inappropriate to treat with Eltrombopag or fails to meet Blueteq approval for use of Eltrombopag using NHS England guidance
* AST \< 3 x upper limit of normal (ULN), bilirubin \< 1.5 x ULN (unless Gilbert's syndrome)
* eGFR \>50mL/min
* Age ≥ 18 years, male or female
* Willing and able to provide written and informed consent
* If female of child-bearing potential, have a negative serum pregnancy test and agree to use adequate contraceptive methods if of reproductive age
* Diffusing capacity for carbon monoxide (DLCO) ≥ 45% predicted corrected for haemoglobin
* LVEF \> 40%.
* Performance status ≤ 2
Exclusion Criteria
* Age \< 18 years' old
* Have a MSD and are eligible for MSD HSCT
* Have a MUD and are eligible for MUD HSCT
* Hypocellular myelodysplastic syndrome (Hypo MDS) or AA/Hypo MDS overlap
* Uncontrolled ongoing infection
* Active malignancy
* Treatment of cancer in the last 5 years (except in situ carcinoma of the cervix or basal cell carcinoma)
* Unable to give informed consent
* Active or uncontrolled infection not responding to appropriate antibiotics and antifungal agents.
* Human immunodeficiency virus (HIV) sero-positivity, hepatitis B, hepatitis C or hepatitis E infection.
* Abnormal organ function: AST/ALT \>3 x upper limit of normal (ULN), bilirubin \>1.5 x ULN, eGFR ≤50mL/min
* Heart failure (= grade III New York Heart Association)
* Pregnant or lactating women
* Unable or unwilling to comply with the contraceptive requirements
18 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Ghulam Mufti
Role: STUDY_DIRECTOR
King's College London
Locations
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King's College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-000082-33
Identifier Type: -
Identifier Source: org_study_id
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