Suicide-Gene t cells aim to stop blood cancer relapse
NCT ID NCT04180059
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether infusing specially designed immune cells can prevent blood cancer from coming back after a stem cell transplant. The cells target a specific protein (HLA-DPB1*04:01) found on many cancer cells and include a 'suicide switch' to turn them off if needed. Six adults with certain blood cancers who have already received a transplant from a donor without that protein will receive increasing doses of these cells. The main goal is to find a safe dose that does not cause severe graft-versus-host disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chu de Nantes
RECRUITINGNantes, France
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