NCT03236129: DLI-Boost

Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells: A Confirmatory, Randomized, Double Blinded Trial

Status unknown Phase 3 Last updated 12 December 2023

What this trial tests

Phase 3 trial testing T-reg depleted DLI in Hematological Malignancies in 52 participants. Status unknown.

Timeline

22 February 2018

Primary endpoint
1 February 2025

1 February 2026

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	22 February 2018
Primary completion	1 February 2025
Estimated completion	1 February 2026
Sites	1 location across France

Drugs / interventions tested

• T-reg depleted DLI — full drug profile →
• Standard DLI

Conditions studied

• Hematological Malignancies — all drugs for Hematological Malignancies →
• Regulatory T Cell Depletion — all drugs for Regulatory T Cell Depletion →
• Relapse — all drugs for Relapse →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Eligibility, any sex, with Hematological Malignancies or Regulatory T Cell Depletion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cumulative incidence of clinical manifestations of GVHD, in the form of acute GVHD with grade ≥ 2 and/or extensive chronic. This parameter will take into account the competitive risk of death unrelated to the GVHD
  Time frame: 3 month after injection

Sponsor's own description

The investigators have previously shown the absence of toxicity of Treg-depleted-DLI and the possibility to triggering alloreactivity (GVHD/GVT) in relapsing patients dealing with hematological malignancies who had never shown any signs of GVHD after transplant or after one or more DLI.

The Investigators, we plan to demonstrate the benefit of Treg-depleted DLI as compared to the reference treatment of relapse in hematological malignancies after allogeneic HSCT which is currently based on standard DLI

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regulatory T cells in homeostasis and disease: molecular mechanisms and therapeutic potential.
   Wang L, Liang Y, Zhao C, Ma P, et al · · 2025 · cited 26× · PMID 41087343 · DOI 10.1038/s41392-025-02326-4
2. Epigenetic regulation of human FOXP3+ Tregs: from homeostasis maintenance to pathogen defense.
   Yue Y, Ren Y, Lu C, Li P, et al · · 2024 · cited 15× · PMID 39144146 · DOI 10.3389/fimmu.2024.1444533
3. TNFR2 blockade of regulatory T cells unleashes an antitumor immune response after hematopoietic stem-cell transplantation.
   Moatti A, Debesset A, Pilon C, Beldi-Ferchiou A, et al · · 2022 · cited 15× · PMID 35387779 · DOI 10.1136/jitc-2021-003508
4. The CCL2-CCR4 axis promotes Regulatory T cell trafficking to canine glioma tissues.
   Panek WK, Toedebusch RG, Mclaughlin BE, Dickinson PJ, et al · · 2024 · cited 8× · PMID 39046599 · DOI 10.1007/s11060-024-04766-4