RecruitingPhase 1Phase 2NCT04707300

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)

A Phase I/II 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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

10 participants

Start Date

Feb 16, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 66 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an innovative approach to speed up immune system recovery after umbilical cord blood stem cell transplants in adults with blood cancers. Researchers are injecting human T lymphoid progenitor cells (HTLPs) — early immune cells — to help rebuild immunity faster after transplant. **You may be eligible if...** - You are between 18 and 65 years old - You have a blood cancer (such as leukemia or lymphoma) that requires an allogeneic stem cell transplant - You do not have a fully matched related or unrelated donor available - Two suitable umbilical cord blood units are available for your transplant **You may NOT be eligible if...** - You have a matched related or unrelated donor available - You are over 65 years old - You have serious organ dysfunction or uncontrolled infection - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman T Lymphoid Progenitor (HTLP) injection

The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0


Locations(5)

Hôpital Saint Louis

Paris, France

Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux

Pessac, France

IUCT Oncopole Toulouse

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Hematology department / Necker Children's Hospital

Paris, Île-de-France Region, France

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NCT04707300


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