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 | Recruiting Phase 1 DMC

• 2 other identifiers: APHP1911162019-004883-23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Hematologic Malignancy

Keywords

acute myeloid leukemia; minimal residual disease; hematologic malignancies; human T Lymphoid Progenitor; umbilical cord blood transplantation

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of grade III-IV graft-versus-host disease (GvHD)

  according to Glucksberg grading system, to define toxicity

  Within 100 Days following HSCT

• CD4 + T cells analysis

  Efficacy defined by the presence of \>50/μl CD4+ CD3+ TCRαβ+ T cells at 2 consecutive measures \< within 4 months post HSCT.

  Within 100 days following HSCT

Secondary Outcomes (15)

• Time to hematologic engraftment

  Up to 24 months post-transplantation

• Last transfusion of platelets and red blood cell

  During the follow-up

• Absolute numbers of neutrophils

  Month 1, 2, 3, 6 and 12 post -transplantation

• Time course of T cell immune reconstitution

  Month 1, 2, 3, 6 and 12 post -transplantation

• Immune phenotype (flow-cytometry analysis) of the different TCRαβ+ cell subpopulations

  Month 1, 2, 3, 6 and 12 post -transplantation

Study Arms (1)

Human T Lymphoid Progenitor (HTLP) injection

EXPERIMENTAL

HTLP cellular product obtained after 7 days of culture of immune-selected CB

Drug: Human T Lymphoid Progenitor (HTLP) injection

Interventions

Human T Lymphoid Progenitor (HTLP) injection DRUG

The HTLP cell suspension will be injected intravenously at the time of UCB HSCT on D0

Human T Lymphoid Progenitor (HTLP) injection

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (5)

Hôpital Saint Louis

Paris, France

RECRUITING

Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux

Pessac, 33604, 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, 75015, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia, Myeloid, Acute; Neoplasm, Residual

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Olivier HERMINE, PhD & MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Elisa MAGRIN, MD

  Département de Biothérapie : Hôpital Necker Enfants malades

  STUDY DIRECTOR

Central Study Contacts

Olivier HERMINE, PhD & MD

CONTACT

+33 144495282; olivier.hermine@aphp.fr

Nelly Briand, PhD

CONTACT

01 44 38 18 62; nelly.briand@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 13, 2021
• Study Start: February 16, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)