NCT04707300 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)
| NCT ID | NCT04707300 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-02-16 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2022-02-16 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Olivier HERMINE, PhD & MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04707300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 66 Years, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04707300 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04707300 currently recruiting?
Yes, NCT04707300 is actively recruiting participants. Contact the research team at olivier.hermine@aphp.fr for enrollment information.
Where is the NCT04707300 trial being conducted?
This trial is being conducted at Paris, France, Pessac, France, Toulouse, France, Villejuif, France and 1 additional location.
Who is sponsoring the NCT04707300 clinical trial?
NCT04707300 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Olivier HERMINE, PhD & MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 10 participants.