Clinical Trials - Cellular Therapy of Cancer
The ECRIN consortium networking activities are designed to promote a harmonised implementation of Good Clinical Practise (GCP) according to directive 2001/20/EC and member of State legislation. ECRIN activities also include training and practise in clinical research and communication with patients, investigators, and citizens.
Information sources
UK:
Gene Therapy Advisory Committee
Medicine and Healthcare Products Regulatory Agency
EU:
Clinigene European Network of Excellence
US:
Recombinant DNA Advisory Committee
Australia - New Zeeland:
Gene and related therapies research advisory panel (GTRAP)
Australian Clinical Trial Registry
Clinical Trials in Cellular Therapy of Cancer
Current Trials
Pending Trials
Completed Trials
Completed Trials
| Title | Intervention | Regulatory Information | Principal Investigator, Site (Country). |
| Phase I Study of Cytokine-Gene Modified Autologous Neuroblastoma Cells for Treatment of Relapsed/Refractory Neuroblastoma | Autologous Bone Marrow Cells, Bone Marrow Transplant | RAC Recommends Approval: 6-1-92/NIH Approval: 8-14-92 Closed to accrual: 1-29-02 |
Brenner, Malcolm K St. Jude Children's Research Hospital, Memphis (USA) |
| Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Adenovirus Encoding the MART-1 Melanoma Antigen |
Type 2/MART-1 Melanoma Antigen/Subcutaneous |
Sole FDA Review Recommended by by NIH/ORDA: 12-1-95 Closed: 9-17-99, follow-up continuing |
Rosenberg, Steven A.; National Institutes of Health, Bethesda, Maryland (USA) |
| Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Adenovirus Encoding the GP100 Melanoma Antigen | Autologous Tumor Cells/Adenovirus/Serotype 2/GP100 Melanoma Antigen/Subcutaneous or Intramuscular Injection/Concurrent Interleukin-2 Therapy |
Sole FDA Review Recommended by NIH/ORDA: 4-19-96 Terminated: 9-17-99 |
Rosenberg, Steven A.; National Institutes of Health, Bethesda, Maryland (USA) |
Current Trials
| Title | Intervention | Regulatory Information | Principal Investigator, Site, (Country) |
|
A Phase I Study of Adoptive |
Autologous transfer of engineered Tcells/Chemotherapy |
GTAC Approval MHRA Approval |
Robert Hawkins Christie Hopsital Manchester (UK) |
| Phase Ia/Ib Trial of 2nd Generation Designer T Cells in Adenocarcinoma | Immunotherapy/ In Vitro/ Autologous T Lymphocytes/ Retrovirus/ Anti-CEA-sFv-Zeta T Cell Receptor-CD28/Intravenous Infusion | Open; RAC Reviewed with Recommendations) NIH/OBA Receipt Date: 1-06-03. Publicly Reviewed at the March 2003 RAC meeting |
Junghans, Richard, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (USA) |
| Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer after Non-Myeloablative Conditioning | Prostate/ Immunotherapy/ In Vitro/Autologous T Lymphocytes/ Retrovirus/anti-PSMA-sFv-Zeta T Cell Receptor-CD 28/ Intravenous Infusion | Open; RAC Reviewed with Recommendations) NIH/OBA Receipt Date: 11-22-04. Publicly Reviewed at the March 2005 RAC meeting |
Junghans, Richard Paul; Roger Williams Medical Center; Providence, Rhode Island (USA) |
| Phase I Study of CD19 Chimeric Receptor Expressing T Lymphocytes in B-Cell Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia | Immunotherapy/ In Vitro/ Autologous T Lymphocytes/ Retrovirus/ CD19 Antigen Specific-Zeta T Cell Receptor/ Intravenous Injections | NIH/OBA Receipt Date: 4-25-06. Not Selected for RAC Public Review: 5-16-06 | Kamble, Rammurti T.; Dotti, Gianpietro; Brenner, Malcolm K.; and Heslop, Helen E. St. Jude Children's Research Hospital, Memphis (USA). |
| Treatment of Patients with Metastatic Melanoma Using Cloned Lymphocytes following the Administration of a Nonmyeloablative but Lymphocyte Depleting Regimen | Peripheral Blood Lymphocytes/ Retrovirus/ Neomycin Phosphotransferase Gene/ Intravenous Infusion | NIH/ORDA Receipt Date: 11-22-99. Not Selected for RAC Public Review: 12-31-99 | Rosenberg, Steven A.; National Institutes of Health, Bethesda, Maryland; (USA) |
| Treatment of Patients with Metastatic Melanoma Using Lymphocytes Transduced with an Interleukin-2 (IL-2) Gene Following the Administration of a Nonmyeloablative but Lymphocyte Depleting Regimen | Autologous T-Lymphocytes/ Interleukin-2 cDNA/ Intravenous or Intra-arterial Infusion | NIH/OBA Receipt Date: 10-10-01. Not Selected for RAC Public Review: 11-14-01 | Rosenberg, Steven A., National Institutes of Health, Bethesda, Maryland; (USA) |
| Phase II Study of Metastatic Cancer that Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-p53 TCR-Gene Engineered Lymphocytes | Immunotherapy/ In Vitro/ Autologous Peripheral Blood Lymphocytes/ Retrovirus/ Anti-p53 TCR Gene/ Intravenous Infusion | NIH/OBA Receipt Date: 2-21-06. Not Selected for RAC Public Review: 3-13-06 | Rosenberg, Steven A.; National Institutes of Health; Bethesda, Maryland (USA) |
| Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma | FDA Approval | Steven A. Rosenberg, MD, PhD, Principal Investigator, NCI - Surgery Branch NCI - Surgery Branch, Bethesda, Maryland, 20892-1201, United States; Recruiting | |
| Chemotherapy Consisting of Fludarabine and Cyclophosphamide Followed By White Blood Cell Infusion, Vaccine Therapy, and Interleukin-2 in Treating Patients With Recurrent or Refractory Metastatic Melanoma | Chemotherapy, therapeutic TIL | FDA Approval | NCI - Surgery Branch, Bethesda, Maryland, 20892-1201, United States; Recruiting Steven A. Rosenberg (USA) |
| Chemotherapy and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, in Treating Patients With Metastatic Melanoma | Chemotherapy, therapeutic TIL | FDA Approval | NCI - Surgery Branch, Bethesda, Maryland, 20892-1201, United States; Recruiting Steven A. Rosenberg |
| Pilot Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRζ and 4-1 BB Signaling Domains in Patients with Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma. Pilot Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRζ and 4-1 BB Signaling Domains in Patients with Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma | Immunotherapy/ In Vitro/ Autologous T Lymphocytes/ Lentivirus/ CD19 Antigen Specific-Zeta T Cell Receptor/ Intravenous Injections | NIH/OBA Receipt Date: 7-24-06. Not Selected for RAC Public Review: 8-14-06 | Porter, David L.; University of Pennsylvania School of Medicine; Philadelphia, Pennsylvania; (USA) |
| Phase I trial to assess the safety of adoptive transfer of cytotoxic T cells specific for Epstein Barr Virus (EBV) latent membrane proteins (LMP) in patients with Stage III and IV nasopharyngeal carcinoma | Autologous T Lymphocytes/ Intravenous Injection | Open to recruitment 05/03/2007 | Dennis Moss Queensland Institute of Medical Research 300 Herston Rd Herston QLD 4006 (Australia) |
| Immuno-gene therapy in Renal Cell Cancer | Adoptive transfer of T cells/ vaccines | VROM – GMO Office: Approval for use of the vector and the clinical protocol CCMO Approval IGZ: GMP certificate Amendment 28.04.2004 |
Erasmus MC, University Medical Centre Rotterdam, (The Netherlands) |
Pending Trials
| Title | Intervention | Regulatory Information | Prinicpal Investigator, Site, (Country) |
| A Phase I Study of Adoptive Transfer ofAutologous Tumour Antigen- Specific T Cells with Pre-conditioning Chemotherapy and Intravenous IL2 in Patients with CD19 Positive Malignancy | Chimeric Immune Receptor CD19-z cDNA Retrovirus |
GTAC Approval MHRA Pending |
Robert Hawkins Christie Research |