Clinical trial NCT01823718: Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: EBV Associated Lymphoma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow transplantation, organ transplantation or patient immunodeficient.

They will receive one to three injections of allogenic CTL specific EBV.

The purpose of this study is to ensure that these injections can not cause a GVH and to study what the side effects are and to see whether this therapy might help patients with Lymphoma.

Immunological monitoring will also be studied.


Eligibility criteria: Inclusion Criteria:

* Male or female, without immunosuppressed organ transplant or immunocompromised and who received a kidney transplant, or kidney-pancreas, or heart or lung or heart-lung, or liver, or cells hematopoietic stem cells, and has given its consent
* Aged 18 to 75 years Children aged more than 12 months,
* PS \<4
* Viral load determined EBV
* Life expectancy\> 1 month
* Patient typed for HLA DP DQ DR ABC
* Patients with lymphoma in the immunosuppressed associated with EBV and failure, partial response (\<50%) or relapsed after treatment with monoclonal antibodies and / or chemotherapy completed for at least three weeks. Patients with partial response may have a PET scan to confirm the lack of response.
* Patient with a measurable mass to assess the response or bone marrow infiltration and / or measurable blood and having frozen tumor material or having a repeat biopsy.
* Availability of a CTL matching at least two HLA or one HLA after validation experts with tumor cells
* test de cytotoxicity negative

Exclusion Criteria:

* Patient Pregnant or lactating
* Concurrent infection with HIV
* EBV negative lymphomas
* If acute GVHD\> grade II J-1 before injection (case grafts CSH)
* Treatment of molecules in pre-marketing authorization older than 21 days
* No matching at least two CTL HLA or non expert validation for the use of CTL with HLA sharing a single tumor
* Test of cytotoxicity positive
* Lack of recognition of tumor cells when available

Primary outcomes:
measure: The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement
timeFrame: 3 months post last injection
Secondary outcomes:
measure: To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
timeFrame: 1 year
Other outcomes:
measure: biological monitoring
timeFrame: 12 months
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Lille
country: France
facility: CHU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hopital Pitié Salpétrière
city: Paris
country: France
facility: Hôpital Necker
Study officials:
References:
citation: Gallot G, Vollant S, Saiagh S, Clemenceau B, Vivien R, Cerato E, Bignon JD, Ferrand C, Jaccard A, Vigouroux S, Choquet S, Dalle JH, Frachon I, Bruno B, Mothy M, Mechinaud F, Leblond V, Milpied N, Vie H. T-cell therapy using a bank of EBV-specific cytotoxic T cells: lessons from a phase I/II feasibility and safety study. J Immunother. 2014 Apr;37(3):170-9. doi: 10.1097/CJI.0000000000000031.