NCT05066958 is a Phase 1, PHASE2 clinical trial of boost anti-viral immunity after T-cell depleted HSCT in Acute Myeloid Leukemia, sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology.

What drugs are being tested in NCT05066958?

Interventions in NCT05066958: boost anti-viral immunity after T-cell depleted HSCT.

What condition does NCT05066958 study?

NCT05066958 studies Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, in Relapse, High Risk Acute Lymphoblastic Leukemia, Acute Biphenotypic Leukemia in Relapse, Non-hodgkin Lymphoma, Myelodysplastic Syndromes.

Is NCT05066958 still recruiting?

NCT05066958 is currently status unknown. Last updated 4 October 2021.

Last reviewed 2021-10-04 · How we verify

NCT05066958

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT

Status unknown Phase 1, PHASE2 Last updated 4 October 2021

What this trial tests

Phase 1, PHASE2 trial testing boost anti-viral immunity after T-cell depleted HSCT in Acute Myeloid Leukemia in 20 participants. Status unknown.

Timeline

16 September 2021

Primary endpoint
1 September 2022

1 December 2022

Quick facts

Lead sponsor	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	16 September 2021
Primary completion	1 September 2022
Estimated completion	1 December 2022
Sites	1 location across Russia

Drugs / interventions tested

boost anti-viral immunity after T-cell depleted HSCT — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
High Risk Acute Myeloid Leukemia — all drugs for High Risk Acute Myeloid Leukemia →
Acute Lymphoblastic Leukemia, in Relapse — all drugs for Acute Lymphoblastic Leukemia, in Relapse →
High Risk Acute Lymphoblastic Leukemia — all drugs for High Risk Acute Lymphoblastic Leukemia →

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Who can join

Adults 1 Month to 18, any sex, with Acute Myeloid Leukemia or High Risk Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HSCT from an allogeneic donor is the standard therapy for high-risk hematopoietic malignancies and a wide range of severe non-malignant diseases of the blood and immune system. The possibility of performing HSCT was significantly limited by the availability of donors compatible with the MHC system. However, modern ex-vivo and in vivo technologies for depletion of T lymphocytes have made it possible to improve the outcomes of HSCT from partially compatible related (haploidentical) donors. In representative groups, it was shown that the success of HSCT from haploidentical donors is not inferior to standard procedures of HSCT from HLA-compatible unrelated donors. HSCT from haploidentical donors in children associated with the deficit of the adaptive immune response, which persists up to 6 months after HSCT and can be an increased risk of death of the patient from opportunistic infections. To solve this problem, the method of infusion of low doses of donor memory T lymphocytes was introduced. This technology is based on the possibility of adoptive transfer of memory immune response to key viral pathogens from donor to recipient. Such infusions have been shown to be safe and to accelerate the recovery of the pathogen-specific immune response. The expansion of virus-specific T lymphocytes in the recipient's body depends on exposure to the relevant antigen in vivo. Thus, in the absence of contact with the viral antigen, the adoptive transfer of memory T lymphocytes is not accompanied in vivo by the expansion of virus-specific lymphocytes and does not form a circulating pool of memory T lymphocytes, that can protect the patient from infections. Therefore the investigators assume that ex-vivo priming of donor memory lymphocytes with relevant antigens can provide optimal antigenic stimulation and may solve the problem of restoring immunological reactivity in the early stages after HSCT. Technically ex-vivo primed memory T lymphocytes will be generated by short incubation of CD45RA-depleted fraction of the graft (a product of T lymphocyte depletion) with a pool of GMP-quality peptides representing a number of key proteins of the viral pathogens. The following are proposed as targeted antigens: CMV pp65, EBV EBNA-1, EBV LMP12A, Adeno AdV5 Hexon, BKV LT, BKV VP1. An infusion of donor memory lymphocytes will be performed on the day +1 after transplantation. Parameters of the assessment will be safety and efficacy (immune response by day 60 and stability (responses by day 180).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Federal Research Institute of Pediatric Hematology, Oncology and Immunology trials

Trials by the same sponsor.

NCT07316595 — Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome · Phase 2 · not yet recruiting
NCT07375563 — Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Ris · Phase 3 · recruiting
NCT07366801 — Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus H · Phase 2, PHASE3 · recruiting
NCT07232134 — The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia · Phase 3 · recruiting
NCT06587191 — Emapalumab Efficacy in Children With Primary Hemophagocytic Lymphohistiocytosis · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05066958 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Last refreshed: 4 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05066958.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing