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

Hadassah Medical Center

Status and phase

Withdrawn

Phase 2

Conditions

Metastatic Solid Tumors

Treatments

Drug: Cell therapy with bispecific antibodies

Study type

Interventional

Funder types

Other

Identifiers

NCT00149019

240502-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.