Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

Hadassah Medical Organization12 enrolled

Overview

Patients with resistant metastatic solid tumors failing all conventional modalities who are eligible for immunotherapy by bispecific antibodies. First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or EpCAM with residual or recurrent disease following NST will be candidates for donor lymphocytes immunotherapy using bispecific antibodies. Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Solid Tumors

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with metastatic solid tumors expressing Her-2/Neu or EpCAM, with available match donor for NST. * Patients with metastatic solid tumors not expected to be cured failing available conventional modalities, age \>18, with no upper age limit. * Patients with metastatic breast cancer failing treatment with Herceptin. * Patients with metastatic cancer cells expressing Her-2/Neu or EpCAM. * Patients with evidence of disease following allogeneic stem cell transplantation with tumor cells expressing Her-2/Neu or EpCAM. * Karnofsky performance status \>60% * Life expectancy \> 3 months, to be able to assess response. Exclusion Criteria: * Patients not fulfilling any of the above. * Patients with active or ongoing infection that may endanger their life, whenever immunosuppression may be counter-indicated. * Pregnant or lactating women. * Patients positive for HIV.

Outcomes

Primary Outcomes

The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.

Secondary Outcomes

To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.