Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes

NCT ID: NCT01823718

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2014-08-31

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.

Conditions

EBV Associated Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Injection of allogenic CTL EBV specific

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Bordeaux

Bordeaux, , France

CHU de Brest

Brest, , France

CHU de Lille

Lille, , France

CHU de Limoges

Limoges, , France

CHU de Nantes

Nantes, , France

Hopital Pitié Salpétrière

Paris, , France

Hôpital Necker

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 24598452 (View on PubMed)

Other Identifiers

04/7-M

Identifier Type: -

Identifier Source: org_study_id