Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human T Lymphoid Progenitor (HTLP) injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Human T Lymphoid Progenitor (HTLP) injection
- description
- HTLP cellular product obtained after 7 days of culture of immune-selected CB
- interventionNames
- Drug: Human T Lymphoid Progenitor (HTLP) injection
Primary outcomes (2)
- measure
- Cumulative incidence of grade III-IV graft-versus-host disease (GvHD)
- timeFrame
- Within 100 Days following HSCT
- description
- according to Glucksberg grading system, to define toxicity
- measure
- CD4 + T cells analysis
- timeFrame
- Within 100 days following HSCT
- description
- Efficacy defined by the presence of \>50/μl CD4+ CD3+ TCRαβ+ T cells at 2 consecutive measures \< within 4 months post HSCT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 66 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available