Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells (ICAR)

Rennes University Hospital

Status and phase: Terminated; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Other: T gamma delta lymphocytes

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00562666

ID RCB 2007-A00249-44

LOC 06/07

CIC 0203/074

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Non inclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 4 patient groups

1

Experimental group

Description:

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

Treatment:

Other: T gamma delta lymphocytes

2

Experimental group

Description:

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

Treatment:

Other: T gamma delta lymphocytes

3

Experimental group

Description:

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

Treatment:

Other: T gamma delta lymphocytes

4

Experimental group

Description:

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

Treatment:

Other: T gamma delta lymphocytes