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Recruiting Phase 1/2

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)

NCT04707300 · tracked via the Priya Life Science France tracker
Phase
Phase 1/2
Started
2022-02-16
Last updated
2026-08-12

Condition(s) studied

Hematologic Malignancy

Investigational drug(s) / intervention(s)

Human T Lymphoid Progenitor (HTLP) injection

Human T Lymphoid Progenitor (HTLP) injection: The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0

Study 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

Sex
ALL
Min age
18 Years
Max age
66 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cumulative incidence of grade III-IV graft-versus-host disease (GvHD) — Within 100 Days following HSCT
    according to Glucksberg grading system, to define toxicity
  • CD4 + T cells analysis — Within 100 days following HSCT
    Efficacy defined by the presence of \>50/μl CD4+ CD3+ TCRαβ+ T cells at 2 consecutive measures \< within 4 months post HSCT.

Trial sites (5)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04707300 on ClinicalTrials.gov ↗ ← All trials in France