Tests HTLP injection to speed immune recovery after cord blood transplant
Tests HTLP injection to help immune recovery in adults with blood cancers.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Paris, Pessac, Toulouse, and Villejuif, FranceSee the 5 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 66 years old?
Source: NCT04707300, who can take part
Where in France
- Hematology department / Necker Children's HospitalParis, FranceTaking people
- Hopital Saint LouisParis, FranceTaking people
- Service d'Hématologie et thérapie cellulaire / CHU of BordeauxPessac, FranceTaking people
- IUCT Oncopole ToulouseToulouse, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT04707300
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Any of the standard contraindications to allogeneic transplant; Concomitant infectious disease: HTLV-I, HIV-I or HIV-II; Previous participation within one month before inclusion in another protocol in which drugs may influence immune reconstitution of bone marrow transplantation; Patients with progressive hematologic malignancies; 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; Pregnancy or breastfeeding for women of childbearing potential.