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Phase I/II Study of inducible HLAG+ Regulatory T Cells (iG-Tregs) in patients undergoing HLA-matched sibling donor allogeneic haematopoietic cell transplantation.
EU CTIS ID: 2024-520084-14-00
What this study is testing
-Determine the maximum tolerated dose (MTD) -Evaluate the safety of iG-Tregs injection from HLA fully compatible donor after allo-HCT to prevent aGvHD.
- Phase I and Phase II (Integrated)- Other
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
- Patient inclusion criteria: 1. Male or female patients aged 18–75 years on the day of informed consent, who have undergone allogeneic hematopoietic cell transplantation (Allo-HCT) from a fully HLA-matched sibling donor. Note: For patients >75 years, transplant eligibility will be assessed after discussion between the Investigator and the patient’s treating physician.
- Donor inclusion criteria: 5. HLA-matched sibling donor of the patient’s hematopoietic stem cells
- Donor inclusion criteria: 6. For WOCBP, negative serum pregnancy test at screening (Day +28) and negative urine pregnancy test before leukapheresis/blood collection (Day +35)
- Patient inclusion criteria: 2. All of the following must be met at initial eligibility assessment and on the day of iG-Treg infusion if the infusion is delayed >14 days from initial assessment: a) Performance status: Karnofsky ≥ 60% b) Adequate hematopoietic and organ function (assessed within last 6 weeks): o Absolute neutrophil count (ANC) >1 x 10^9/L o Serum creatinine ≤2 mg/dL or GFR >40 mL/min/1.73 m² o AST or ALT <3 x upper limit of normal (ULN) o Total bilirubin ≤2.5 mg/dL (not applied to participants with Gilbert’s syndrome) o Albumin >2.5 g/dL o Oxygen saturation ≥92% on room air o Chest X-ray or CT scan without signs of infection o No significant cardiac disease and/or left ventricular ejection fraction >35% on echocardiogram
- Patient inclusion criteria: 3. Women of Childbearing Potential (WOCBP): Negative serum pregnancy test within 28 days before study entry Negative urine pregnancy test at eligibility confirmation (Day +56) and prior to iG-Treg infusion (Day +63) Agreement to use a highly effective method of contraception throughout the study and for ≥3 months after last IMP administration Highly effective contraception methods include: Hormonal contraception (combined or progestin-only, oral, injectable, transdermal, or implantable) Intrauterine device (IUD) or intrauterine system (IUS) Bilateral tubal occlusion Permanent sexual abstinence, if consistent with lifestyle / Women Not of Childbearing Potential (WONCBP): Eligible without requirement for pregnancy testing or contraception Defined as women who are surgically sterile (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy) or postmenopausal (≥12 consecutive months of amenorrhea without alternative medical cause) / Male Participants: Must use condoms (with or without spermicide) during study and for ≥3 months after IMP administration Must ensure female partner uses highly effective contraception for the same period Sperm donation is prohibited during study and for same period post-study
- Patient inclusion criteria: 4. Ability to understand and willingness to sign the approved informed consent form after explanation
You likely can't join if
- 1. aGvHD grade ≥II (per Appendix 1) or receiving systemic first-line therapy for any aGvHD. Skin GvHD grade II allowed
- Patients with evidence of minimal residual disease during final assessment by consultant haematologist.
- Uncontrolled infections unresponsive to treatment. Prophylactic therapy for CMV or EBV reactivation without disease evidence is allowed
- HBV, HCV ή HIV positive patients
- Receipt of any investigational agent ≤28 days before iG-Treg infusion. Agents outside study indication administered post-transplant (e.g., valganciclovir for CMV, MMF for GvHD prophylaxis) are allowed
See the full eligibility criteria
Who can join
- Patient inclusion criteria: 1. Male or female patients aged 18–75 years on the day of informed consent, who have undergone allogeneic hematopoietic cell transplantation (Allo-HCT) from a fully HLA-matched sibling donor. Note: For patients >75 years, transplant eligibility will be assessed after discussion between the Investigator and the patient’s treating physician.
- Donor inclusion criteria: 5. HLA-matched sibling donor of the patient’s hematopoietic stem cells
- Donor inclusion criteria: 6. For WOCBP, negative serum pregnancy test at screening (Day +28) and negative urine pregnancy test before leukapheresis/blood collection (Day +35)
- Patient inclusion criteria: 2. All of the following must be met at initial eligibility assessment and on the day of iG-Treg infusion if the infusion is delayed >14 days from initial assessment: a) Performance status: Karnofsky ≥ 60% b) Adequate hematopoietic and organ function (assessed within last 6 weeks): o Absolute neutrophil count (ANC) >1 x 10^9/L o Serum creatinine ≤2 mg/dL or GFR >40 mL/min/1.73 m² o AST or ALT <3 x upper limit of normal (ULN) o Total bilirubin ≤2.5 mg/dL (not applied to participants with Gilbert’s syndrome) o Albumin >2.5 g/dL o Oxygen saturation ≥92% on room air o Chest X-ray or CT scan without signs of infection o No significant cardiac disease and/or left ventricular ejection fraction >35% on echocardiogram
- Patient inclusion criteria: 3. Women of Childbearing Potential (WOCBP): Negative serum pregnancy test within 28 days before study entry Negative urine pregnancy test at eligibility confirmation (Day +56) and prior to iG-Treg infusion (Day +63) Agreement to use a highly effective method of contraception throughout the study and for ≥3 months after last IMP administration Highly effective contraception methods include: Hormonal contraception (combined or progestin-only, oral, injectable, transdermal, or implantable) Intrauterine device (IUD) or intrauterine system (IUS) Bilateral tubal occlusion Permanent sexual abstinence, if consistent with lifestyle / Women Not of Childbearing Potential (WONCBP): Eligible without requirement for pregnancy testing or contraception Defined as women who are surgically sterile (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy) or postmenopausal (≥12 consecutive months of amenorrhea without alternative medical cause) / Male Participants: Must use condoms (with or without spermicide) during study and for ≥3 months after IMP administration Must ensure female partner uses highly effective contraception for the same period Sperm donation is prohibited during study and for same period post-study
- Patient inclusion criteria: 4. Ability to understand and willingness to sign the approved informed consent form after explanation
- Patient inclusion criteria: 5. Patient must be on continuous GvHD prophylaxis with cyclosporine (CsA) at therapeutic levels (>200 ng/mL) from Day -3 pre-transplant up to before study inclusion
- Donor inclusion criteria: 1. If donor undergoes leukapheresis (for collection of donor lymphocytes), they must meet standards according to institutional SOPs and FACT-JACIE donor selection criteria; leukapheresis of therapeutic cells must be performed without G-CSF administration
- Donor inclusion criteria: 2. Ability and willingness to provide written informed consent specific to this study
- Donor inclusion criteria: 3. Male or female aged 18–65 years at time of consent
- Donor inclusion criteria: 4. Body weight >40 kg and in good clinical condtition
What rules you out
- 1. aGvHD grade ≥II (per Appendix 1) or receiving systemic first-line therapy for any aGvHD. Skin GvHD grade II allowed
- Patients with evidence of minimal residual disease during final assessment by consultant haematologist.
- Uncontrolled infections unresponsive to treatment. Prophylactic therapy for CMV or EBV reactivation without disease evidence is allowed
- HBV, HCV ή HIV positive patients
- Receipt of any investigational agent ≤28 days before iG-Treg infusion. Agents outside study indication administered post-transplant (e.g., valganciclovir for CMV, MMF for GvHD prophylaxis) are allowed
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.