Infusion of CTL Anti-DP after stem cell transplantation
A Phase 1 Dose-escalation Study Testing the Feasibility and the Tolerance of Infusion of a Specific Third Party Suicide Gene-transduced Anti-HLA-DPB1*0401 CD4+ T Cell Clone in HLA-DPB1*04:01 Positive Tumor Recipients Receiving an Allotransplant From a HLA-DPB1*04:01 Negative Donor.
This study is testing whether giving special immune cells after a stem cell transplant can help prevent cancer from coming back while reducing side effects for patients with blood cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT04180059 on ClinicalTrials.gov |
What this trial studies
This study investigates the infusion of cytotoxic T lymphocytes (CTL) targeting HLA-DP in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) for hematologic malignancies. The aim is to enhance the graft-versus-tumor effect while minimizing the risk of graft-versus-host disease (GVHD). Eligible patients are those in complete remission or with significant response at the time of transplant, receiving cells from HLA-DPB1 negative donors. The study seeks to determine the safety and efficacy of this approach in preventing disease relapse post-transplant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with specific hematologic malignancies who are HLA-DPB1*04:01 positive and undergoing allo-HSCT from HLA-DPB1*04:01 negative donors.
Not a fit: Patients who are not HLA-DPB1*04:01 positive or those with advanced disease not in remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve long-term outcomes and survival rates for patients with high-risk hematologic malignancies post-transplant.
How similar studies have performed: Other studies have shown promise in using T cell therapies post-transplant, but this specific approach targeting HLA-DP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients HLA-DPB1\*04:01 positive, with confirmed diagnosis of hematologic malignancies (AML, Myelodysplasic and myeloproliferative syndrome, ALL, non-Hodgkin's lymphoma, Hodgkin's disease, CLL), undergoing an allo-HSCT using a HLA-DPB1\*04:01 negative donor. * The graft can be PBSC (peripheric blood stem cells) or bone marrow. * Patients aged between 18-75 years. * Patients in complete remission or \>50% of response (for lymphoma) at time of transplant. * have a donor with no contra-indications for mobilization of peripheral blood stem cells using G-CSF (colony-stimulating factors) * Affiliation number to the National Health Care System * Lack of reactivity of the clone against the donor's cells (PHA-blasts prepared for from PBMCs). * For cord blood transplants: cord blood must be HLA-DPB1\*04:01 negative and the HLA compatibility (A, B, DR) between the cord blood and the recipient must be 4/6, 5/6 or 6/6. * ECOG \<=2 or Karnofsky \>60% * neutrophils ≥ 1 000 cells /μl and/or platelets ≥ 50 000 cells/μl (growth factor allowed) Exclusion Criteria: * pregnant or breastfeeding woman * patient refusing contraception measure * minor * Adult patients under guardianship, curatorship or justice protection * Patients with post-transplant relapse within the clone injection time (before D100) * Karnofsky performance score below 60%or ECOG \>2 * Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease. * Severe liver failure (bilirubin \>30 µmoles/L, SGPT (Serum Glutamo-Oxalacetic Transaminase)\> 4 X upper limit of normal). * Impaired renal function (creatinine clearance \< 30 ml/min) * Acute GVHD \> grade 1 * Active uncontrolled infection. * Denied to provide informed consent * Severe neurological or psychiatric disorders as determined by the study physician. * Treatment with other investigational drugs following allogeneic transplantation.
Where this trial is running
Nantes
- Chu de Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: thierry GUILLAUME, MD
- Email: thierry.guillaume@chu-nantes.fr
- Phone: 02.40.08.48.45
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.