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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 75

Infusion of CTL Anti-DP after stem cell transplantation

Official title: 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.

Run by Nantes University Hospital · NCT04180059 · Data updated 2026-11-12

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.

More Haematologic Disease trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment6 (estimated)
SponsorNantes University Hospital
Academic / other
Locations1 site (Nantes)
StatusRecruiting
StartedFebruary 9, 2020
Main results expectedJuly 2027
Study endsAugust 2027
Registry record updatedJanuary 26, 2026
Trial IDNCT04180059 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using T cell therapies post-transplant, but this specific approach targeting HLA-DP is relatively novel.

Who can join: the full rules

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 it's running

  • Chu de Nantes
    Nantes, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.