Phase I / II study of HLA-G + induced T-regulatory cells (iG-Tregs) in patients after allogeneic hematopoietic stem cell transplantation from HLA compatible sibling / donor.

Phase 1

• Conditions: Adopt immunotherapy in adult patients undergoing hematopoietic stem cell (HSCT) transplantation from a fully compatible donor sibling for the prevention and treatment of GvHD.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-006367-26-GR
• Lead Sponsor: ?a?ep?st?µ?? ?at???

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-17
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Patients
1.Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) from a fully HLA compatible donor sibling.
2. All of the following should be met during the initial evaluation assessment and the day of the iGTreg injection in case the iGTreg injection day is delayed> 14 days after the initial evaluation
a) Operating status: Karnofsky = 60%
b) Adequate hematopoiesis and organ function, in evaluation of the last 6 weeks:
c) Negative pregnancy test within 28 days of inclusion in the study (valid only for women of childbearing potential) AND before iG-Tregs injection
3. Consent to use effective contraception during the transplant period (only applies to sexually active women of childbearing potential and men)
4. Ability to understand and willingness to sign the informed consent form
5. The patient should be on constant prophylaxis of CsA (from day -3) at therapeutic levels (> 200 ng / ml) prior to admission.
Donor
1. The donor will be evaluated and meet the requirements according to the procedures of the institution and according to the JACIE standards to undergo leukophase (donor lymphocytes) without stimulation with G-CSF.
2. The donor should have the ability to understand and be willing to sign a written consent upon information specifically for this study.
3. Age 16-75 years
4. Body weight> 40 kg and good general health
5. HLA-fully compatible brother who is also the donor of the participating patient's hematopoietic stem cells
6. Negative pregnancy test (valid only for women of reproductive age)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Grade aGvHD =II (according to the criteria listed in Annex 1) or receiving systemic first-line treatment for the purchase of aGvHD. Stage II of GvHD skin (Grade I) is allowed.
2. Patients with signs of Residual Disease in their last hematological evaluation.
3. Uncontrolled infections that do not respond to treatment. Prophylactic treatment to reactivate CMV or EBV in the absence of evidence of CMV or EBV disease.
4. HBV, HCV or HIV positive individuals
5. Taking any research agent = <28 days before iG Treg injections. Non-indicative agents administered after transplantation (eg valcyte for CMV activation, MMF for GvHD prophylaxis) are allowed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified