Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells

NCT ID: NCT00562666

Last Updated: 2012-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-01-31

Brief Summary

For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes

Group Type: EXPERIMENTAL

T gamma delta lymphocytes

Intervention Type: OTHER

Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

2

Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes

Group Type: EXPERIMENTAL

T gamma delta lymphocytes

Intervention Type: OTHER

Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

3

Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes

Group Type: EXPERIMENTAL

T gamma delta lymphocytes

Intervention Type: OTHER

Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

4

Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes

Group Type: EXPERIMENTAL

T gamma delta lymphocytes

Intervention Type: OTHER

Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

Interventions

T gamma delta lymphocytes

Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult over 18
• Hepatocellular carcinoma histologically proven, with at least one measurable tumor
• Non operable tumor
• Alfa foeto protein > 400 ng/ml
• Other treatments (surgery, chemoembolization) non indicated
• Chemoembolization non indicated due to good performance status (WHO 1) or to tumor volume
• Performance status WHO < 2
• Life expectancy > 3 months

• Extra hepatic metastases
• Severe hepatopathy (Child B or C)
• Virus B or C chronic hepatitis
• Chronic cardiac failure
• Uncontrolled severe infectious disease
• Other cancer, if not considered as cured
• Positive serology for HIV or HTLV
• Leucocytes < 3000/mm3 or neutrophils < 1500/mm3
• Platelets < 80000/mm3
• Serum creatinine > 110 µmol/L
• Bilirubin > 35 µmol/L
• AST, ALT, alkaline phosphatase > 5N
• Current immunosuppressive treatment
• Impossibility to comply with scheduled follow-up
• Anatomical situation not permitting the selective injection of the product of cell therapy
• Pregnant or breastfeeding woman, or not using adequate effective contraceptive method

Exclusion Criterion:

• Insufficient number of gamma delta lymphocytes after expansion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innate Pharma

INDUSTRY

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc RAOUL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CRLCC Eugène Marquis, Rennes

Eric BELLISSANT, MD, PhD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes

Rennes, , France

Département d'Oncologie Médicale - CRLCC Eugène Marquis

Rennes, , France

Service de Chirugie Viscérale - Hôpital de Pontchaillou

Rennes, , France

Countries

France

Other Identifiers

CIC 0203/074

Identifier Type: -

Identifier Source: secondary_id

LOC 06/07

Identifier Type: -

Identifier Source: secondary_id

ID RCB 2007-A00249-44

Identifier Type: -

Identifier Source: org_study_id