Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO)
Condition(s) studied
Investigational drug(s) / intervention(s)
Human T Lymphoid Progenitor (HTLP) injection: The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0
Study summary
This is an open-labelled and non-controlled Phase I/II clinical trial, evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies. The dose limiting toxicity of HTLP injection will be evaluated using a model-based design.
Eligibility
Primary outcome measure(s)
- Cumulative incidence of grade III-IV graft-versus-host disease (GvHD) — Within 100 Days following HSCT
according to Glucksberg grading system, to define toxicity - CD4 + T cells analysis — Within 100 days following HSCT
Efficacy defined by the presence of \>50/μl CD4+ CD3+ TCRαβ+ T cells at 2 consecutive measures \< within 4 months post HSCT.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Saint Louis | Paris | France | Recruiting |
| Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux | Pessac | France | Recruiting |
| IUCT Oncopole Toulouse | Toulouse | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Not Yet Recruiting |
| Hematology department / Necker Children's Hospital | Paris | Île-de-France Region | Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04707300 on ClinicalTrials.gov ↗ ← All trials in France