Using Human T Lymphoid Progenitor Injection to Boost Immune Recovery After Cord Blood Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of Human T Lymphoid Progenitor (HTLP) injections aimed at accelerating immune reconstitution in adult patients with hematologic malignancies following umbilical cord blood (UCB) transplantation. The study is open-label and non-controlled, focusing on patients who do not have a matched sibling or unrelated donor. It aims to reduce the risk of infections and relapse by enhancing T-cell-mediated immunity post-transplant. The trial will assess dose-limiting toxicity using a model-based design to ensure patient safety and treatment effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (≥ 18 years old and \<66 years old) at the time of inclusion and eligible for an allogeneic stem cells transplantation and fit to receive the specified conditioning regimen
* Patients with hematologic malignancies
* Absence of a matched - related sibling donor (MSD) or a matched unrelated donor (MUD) 10/10
* Presence of two UCB units with the following criteria\*: HLA- matched 4/8, 5/8, 6/8, 7/8 or 8/8 for HLA- A, -B, -C and DRB1 loci

AND

• Presence of at least one UCB unit with the following criteria\*: ≥ 3 x 10e7 TNC/kg or ≥ 1.5 10e5 CD34+/kg pre- freezing

\* For the UCB taken into HTLP culture, the CD34+ content does not need to meet the above cellularity criteria, as expansion during HTLP culture has been proven to ensure the appropriate number of CD7+ needed for each dose.

The non- cultured UCB will be chosen to have a higher CD34+ cell content in order to enable long- term hematopoietic engraftment

* Absence of Donor Specific Antibodies (DSA) with a MFI \> 5000
* Patient affiliated to social security
* Written, informed consent of the patient

Exclusion Criteria:

* Any of the standard contraindications to allogeneic transplant
* Left ventricular ejection fraction \<50%
* Abnormal biochemistry results (ALT/AST\>10xULN, total bilirubin\>2.5xULN, creatinin clearance \<60ml/min)
* Inability to understand and provide informed consent
* Concomitant infectious disease: HTLV-I, HIV-I or HIV-II
* Pregnancy or breastfeeding for women of childbearing potential
* Patients with progressive hematologic malignancies
* Previous participation within one month before inclusion in another protocol in which drugs may influence immune reconstitution of bone marrow transplantation

Where it's running

• Hôpital Saint Louis
  Paris, France Recruiting
• Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux
  Pessac, France Recruiting
• IUCT Oncopole Toulouse
  Toulouse, France Recruiting
• Hematology department / Necker Children's Hospital
  Paris, Île-de-France Region, France Recruiting
• Institut Gustave Roussy
  Villejuif, France Not yet recruiting

Study contacts

• Principal investigator: Olivier HERMINE, PhD & MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Olivier HERMINE, PhD & MD
• Email: olivier.hermine@aphp.fr
• Phone: +33 144495282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.