Using Human T Lymphoid Progenitor Injection to Boost Immune Recovery After Cord Blood Transplant
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
PHASE1; PHASE2 · Assistance Publique - Hôpitaux de Paris · NCT04707300
This study is testing if injections of a special type of immune cell can help adults with blood cancers recover their immune system faster after receiving a cord blood transplant.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 66 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 5 sites (Paris and 4 other locations) |
| Trial ID | NCT04707300 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Human T Lymphoid Progenitor (HTLP) injections aimed at accelerating immune reconstitution in adult patients with hematologic malignancies following umbilical cord blood (UCB) transplantation. The study is open-label and non-controlled, focusing on patients who do not have a matched sibling or unrelated donor. It aims to reduce the risk of infections and relapse by enhancing T-cell-mediated immunity post-transplant. The trial will assess dose-limiting toxicity using a model-based design to ensure patient safety and treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with hematologic malignancies who are eligible for allogeneic stem cell transplantation and lack a matched donor.
Not a fit: Patients with matched related or unrelated donors, or those outside the specified age range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infections and improve survival rates for patients undergoing UCB transplantation.
How similar studies have performed: While the approach of using HTLP injections is innovative, similar studies in enhancing immune recovery post-transplant have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 4 other locations
- 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, France (RECRUITING)
Study contacts
- Principal investigator: Olivier HERMINE, PhD & MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Olivier HERMINE, PhD & MD
- Email: olivier.hermine@aphp.fr
- Phone: +33 144495282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematologic Malignancy, acute myeloid leukemia, minimal residual disease, hematologic malignancies, human T Lymphoid Progenitor, umbilical cord blood transplantation