Clinical trial · Interventional
T Lymphocytes (LT) Expressing iCASP9 and ΔCD19 in Allogeneic Haematopoietic Transplantation.
Use of Genetically Modified T-lymphocytes Expressing the Inducible Human Caspase 9 Gene (iCASP9) and the Selection Gene ΔCD19 in Allogeneic Haematopoietic Transplantation.
NCT02849886CI-TRIAL-00091906Side_by_CideterminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): not enough recruitment because of new therapeutic alternatives
Summary
Brief summary (as posted)
This study evaluates the frequency of occurrence, severity, and response to treatment by a chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the case of acute Graft versus Host Disease (aGvHD) occurring after the administration of T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and T-lymphocytes
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dimerizer drug AP1903 | Drug | — | UNRESOLVED |
| T lymphocytes iCASP9 ΔCD19 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LT icasp9 ΔCD19 (cohort1)
- description
- Injection T lymphocytes iCASP9 ΔCD19 (2.10e6, 5.10e6 and 10.10e6 Gene Modified Cells (GMC)/kg).
- interventionNames
- Drug: T lymphocytes iCASP9 ΔCD19
- type
- EXPERIMENTAL
- label
- LT iCASP9 ΔCD19 & GvHD (cohort2)
- description
- Injection T lymphocytes iCASP9 ΔCD19 (2.10e6, 5.10e6 and 10.10e6 GMC/kg). Patients who develop GVHD after administration of Gene Modified Cells (GMC) will be treated with dimerizer drug (AP1903)
- interventionNames
- Drug: T lymphocytes iCASP9 ΔCD19
- Drug: Dimerizer drug AP1903
Primary outcomes (1)
- measure
- GvHD response to Dimerizer AP1903
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients aged ≤55 years (40\< age ≤55 years); * Patients who are candidates for myeloablative allogeneic bone marrow transplants: de novo or secondary acute lymphoblastic leukaemia (ALL) and acute myeloblastic leukaemia (AML) in complete remission (CR) ≥1; chronic myeloid leukaemia (CML) in chronic phase or in escape from tyrosine kinase inhibitors; myelodysplastic syndrome (MDS) with int-2 or high International Prognostic Scoring System (IPSS score, with medullary blastosis \>10%); chemosensitive malignant non-Hodgkin's lymphoma (MNHL) in CR or partial remission (PR) \>2 ; chemosensitive Hodgkin's disease in CR or PR \>2 ; chemosensitive chronic lymphoid leukaemia (CLL) in CR or PR \>2; chemosensitive myeloma in CR or PR ≥2; * At high risk for GvHD: the risk for GvHD is considered high and the patient thus eligible for the study, if the receiver is \>40 years, or if the donor is a woman and the receiver a man, regardless their age; * Karnofsky index \>70% or World Health Organization (WHO) index ≥2; * Stable clinical conditions and life expectancy \>3 months; * Absence of organic disease contraindicating the transplantation * Availability of a genotypically identical donor, aged \>18 years, having given consent, and presenting no contraindications to bone marrow donation under general anaesthesia and to the required apheresis procedures; * Written informed consent of the donor and patient. Exclusion Criteria: * Age \<40 years or \> 55 years * Organic disease contraindicating the utilisation of myeloablative conditioning * History of allogeneic Hematological Stem Cell Transplantation (HSCT); * History of autologous HSCT \<1 year prior to the date for the scheduled allogeneic HSCT; * Neurological location of the haemopathy justifying the transplantation; * Pregnant or breastfeeding woman; * Positive HIV serology; * Positive hepatitis B or hepatitis C serology (except for post-vaccinal hepatitis B status); * Absence of informed consent from the receiver or donor; * Inability to adhere to the protocol instructions.
References
Publications (0)
Data not yet available
No reference posted for this study.