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First Clinical Trial with activated regulatory T-cells in patients early after haematopoietic stem cell transplantation (HSCT)
EU CTIS ID: 2024-516599-14-00
What this study is testing
To assess the safety and tolerability of ATreg
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged >= 18years, any gender (m/f/d)
- Willing and able to provide written informed consent
- Healthy 3rd party donor available
- Meets all criteria for a HSCT and the HSCT (source either peripheral blood or bone marrow, any HLA status, any AB0 blood group status) is planned
- Patients with HLA compatible HSCT (10/10 or 9/10 matched donor)
- Hematologic malignancy such as AML, MDS, ALL, MM, MPN, lymphoma (B-NHL and Hodgkin lymphoma) that needs HSCT
You likely can't join if
- Patients after haploidentical HSCT
- Has been treated with prednisolone at >2 mg/kg/day (or equivalent dosing of alternative glucocorticosteroids) at time of ATreg infusion
- Has a clinical manifestation of acute GvHD (any grade)
- Has known contraindications to the protocol specified treatments/medication
- Has known allergy/hypersensitivity to any component of the study product
- Is a pregnant or nursing woman. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective form of contraception during participation in the study from time of inclusion until 2 months after ATreg therapy
See the full eligibility criteria
- Adults aged >= 18years, any gender (m/f/d)
- Willing and able to provide written informed consent
- Healthy 3rd party donor available
- Meets all criteria for a HSCT and the HSCT (source either peripheral blood or bone marrow, any HLA status, any AB0 blood group status) is planned
- Patients with HLA compatible HSCT (10/10 or 9/10 matched donor)
- Hematologic malignancy such as AML, MDS, ALL, MM, MPN, lymphoma (B-NHL and Hodgkin lymphoma) that needs HSCT
- Has a life expectancy of >6 weeks
- Patients after haploidentical HSCT
- Has been treated with prednisolone at >2 mg/kg/day (or equivalent dosing of alternative glucocorticosteroids) at time of ATreg infusion
- Has a clinical manifestation of acute GvHD (any grade)
- Has known contraindications to the protocol specified treatments/medication
- Has known allergy/hypersensitivity to any component of the study product
- Is a pregnant or nursing woman. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective form of contraception during participation in the study from time of inclusion until 2 months after ATreg therapy
- Is not willing to comply with all clinical study procedures
- Has any other known medical condition which is considered to be clinically significant, which in the opinion of the Investigator would affect study participation, the performance or interpretation of study assessments or make the patient incapable to understand the nature, scope, and possible consequences of the study
- Has had any other malignancy within the last 3 years
- Is housed in an institution under a court or official order
- Has a severe uncontrolled infection (Investigator decision)
- Has a HIV infection or an active HBV or HCV infection
- Has participated in another investigational study within 14 days of inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.