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Hematologic MalignancyPhase 1/2HTLP-ONCONCT04707300

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 1/2 study testing Human T Lymphoid Progenitor (HTLP) injection in people with Hematologic Malignancy, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 66 years
Conditions the study is for
Hematologic Malignancy
What is being tested?
Human T Lymphoid Progenitor (HTLP) injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
5 sitesFrance
Study dates
16 Feb 2022to Feb 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olivier HERMINE, PhD & MD contact

+33 144495282

olivier.hermine@aphp.fr

Nelly Briand, PhD contact

01 44 38 18 62 ext. +33

nelly.briand@aphp.fr

5 sites in 1 country

France5 sites, 5 recruiting

  • Hôpital Saint Louis

    Paris

    Nicolas BOISSEL, MD, PhD, +33 1 42 49 96 43, nicolas.boissel@aphp.fr

    Recruiting

  • Hematology department / Necker Children's Hospital

    Paris, Île-de-France Region, 75015

    Olivier HERMINE, PhD & MD, +33 144495282, olivier.hermine@aphp.fr

    Felipe SUAREZ, PhD & MD, felipe.suarez@aphp.fr

    Recruiting

  • Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux

    Pessac, 33604

    Edouard FORCADE, PhD & MD, edouard.forcade@chu-bordeaux.fr

    Recruiting

  • IUCT Oncopole Toulouse

    Toulouse

    Anne HUYNH, PhD, MD, 05 31 15 71 91, huynh.anne@iuct-oncopole.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Jean-Henri BOURHIS, PhD MD, +33 1 42 11 53 82, jean-henri.bourhuis@gustaveroussy.fr

    Not yet recruiting

Other trials in France

About this study

Official title: 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.

Read the detailed description

Allogeneic bone marrow transplantation (AlloSCT) is the treatment of choice for high- risk acute myeloid leukemias in complete first remission after induction therapy and other high-risk hematological malignancies. Umbilical cord blood grafts are frequently used for patients lacking an HLA- matched family donor (Matched-sibling donor, MSD) as well as in the absence of an appropriate unrelated donor (10/10 MUD). As any HSCT, UCB transplantations are associated with the risk of acute and chronic GVHD, post- transplant immunodeficiency with increased risk of infections as well as relapse. Especially the risk of infection and therefore non- relapse mortality (NRM) or transplant- related mortality (TRM) is significantly higher in UCB transplantations as compared to MSD or 10/10 MUD transplantations. All of these risks have been linked to a significant delay in immune reconstitution including various immune cell populations like CD4 and CD8 T cells, Treg, NK, iNKT, pDC and others.

The investigators therefore make the hypothesis that if T-cell-mediated immunity was rapidly generated after a partially HLA-compatible UCB transplantation will reduce the risk of infection and to prevent relapse without increasing the risk of GVHD.

Being tested
Human T Lymphoid Progenitor (HTLP) injection
Keywords
acute myeloid leukemia, minimal residual disease, hematologic malignancies, human T Lymphoid Progenitor, umbilical cord blood transplantation
Medical subject headings
Hematologic Neoplasms, Leukemia, Myeloid, Acute, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human T Lymphoid Progenitor (HTLP) injectionDrug

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

Study groups in NCT04707300
Study groupRoleWhat they receive
Human T Lymphoid Progenitor (HTLP) injectionExperimentalHTLP cellular product obtained after 7 days of culture of immune-selected CB
Receives: Drug: Human T Lymphoid Progenitor (HTLP) injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    according to Glucksberg grading system, to define toxicity

    Measured: Within 100 Days following HSCT

  2. 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.

    Measured: Within 100 days following HSCT

Secondary outcomes (15)

  1. Time to hematologic engraftment

    ANC > 0.5G/L and platelets > 20G/L on 3 consecutive days

    Measured: Up to 24 months post-transplantation

  2. Last transfusion of platelets and red blood cell

    Measured: During the follow-up

  3. Absolute numbers of neutrophils

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

  4. Time course of T cell immune reconstitution

    by immunophenotyping (flow cytometry analysis) - with a focus on time needed to exceed a count of 100 naive CD4+ and >100 total CD8+ cells per μL

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

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

    TCD4 naive/memory population (CD31+CD45RA+/CD4+, CD45RO/CD4+; CD31+CD4+); TCD8 naive/memory population (CD45RA+CCR7+/CD8+, CD45RA-CCR7+/ CD8+, CD45RA- CCR7+/ CD8+, CD45RA-CCR7-/CD8+) , CD8 effector memory RA+ (TEMRA) (CD45RA+CCR7- /CD8+ ); Regulatory T cells (CD4+CD25+CD127lowCD25+).

    • Analysis of CD3, CD4, CD8 numbers will be performed if total lymphocytes ≥ 500/μL and analysis of T cell subpopulations if CD3+ cells ≥ 1000/μL

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

  6. B-cell reconstitution

    (B CD19 naive/memory population (CD27-IgD+/CD19+, CD27+IgD+/CD19+, CD27+IgD-/CD19 and Ig levels) at 1, 2, 3, 6 and 12 months post HSCT with focus on time needed for cessation of intravenously IgG replacement therapy

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

  7. Reconstitution of the NK cell

    compartment (CD16+CD56+)

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

  8. Assessment of engraftment of each UCB unit over time by hematological monitoring and chimerism analysis

    at 1, 2, 3, 6 and 12 months following HSCT and between M1 and M2 post-transplantation if necessary according to the result of the chimerism at M1 on neutrophils, T, B, NK, pDC and macrophages.

    • The chimerism is studied on whole blood and on mononuclear cells (i.e. cells reconditioning after Ficoll) until the total number of lymphocyte is ≥ 100/μL.

    When lymphocyte count is ≥ 100/μL, the chimerism will be analysed on immunoselected cell populations (CD15+/CD3+/NK, CD19+)

    Measured: at 1, 2, 3, 6 and 12 months following HSCT.

  9. Graft failure/rejection rate

    detected by hematological monitoring of each UCB unit

    Measured: at 3 months following HSCT

  10. Cumulative incidence of infections

    Measured: at 3, 6 and 12 months post- transplantation

  11. Cumulative incidence of acute and chronic episodes of GVHD and their grade according to Glucksberg GvHD staging.

    Measured: at 3, 6, 12 and 24 months post-transplantation

  12. Relapse rate

    Measured: 2 years

  13. Overall survival

    Measured: 2 years

  14. Disease-free survival

    Measured: 2 years

  15. Progression-free survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start16 Feb 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707300
Sponsor's protocol ID
APHP191116
Other IDs
2019-004883-23, 2019
Acronym
HTLP-ONCO
Status last verified
Aug 2026
First submitted
30 Nov 2020
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Human T Lymphoid Progenitor (HTLP) injection in people with Hematologic Malignancy, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivier HERMINE, PhD & MD (+33 144495282, olivier.hermine@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of grade III-IV graft-versus-host disease (GvHD) (time frame: Within 100 Days following HSCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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