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

Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149019

Enrollment

Registered

2005-09-08

Start date

2002-05-31

Completion date

2005-09-30

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Solid Tumors

Brief summary

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.

Interventions

DRUGCell therapy with bispecific antibodies

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026