Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2022
août 2028
02 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | HERMINE Olivier | 18/10/2025 09:41:17 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/04/2025 07:55:23 | Contacter | |||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Saint Louis | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Saint Louis - Paris 2988507 - France | Nicolas BOISSEL, MD, PhD | 18/10/2025 09:41:17 | Contact (sur clinicalTrials) | ||
| IUCT Oncopole Toulouse - Toulouse 2972315 - France | Anne HUYNH, PhD, MD | 18/10/2025 09:41:17 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux - 33604 - Pessac 2987805 - France | Edouard FORCADE, PhD & MD | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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