Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.
|ClinicalTrials.gov Identifier: NCT00149019|
Recruitment Status : Withdrawn (the PI is no longer work at Hadassah)
First Posted : September 8, 2005
Last Update Posted : April 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Solid Tumors||Drug: Cell therapy with bispecific antibodies||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.|
|Study Start Date :||May 2002|
|Estimated Study Completion Date :||September 2005|
- The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
- To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149019
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Shimon Slavin, MD||Hadassah Medical Organization|