Date: 2017-05-16
Type of
information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Adaptimmune (UK)
Product: autologous genetically modified T-cells expressing an affinity optimized T-cell receptor (TCR) specific for MAGE-A4
Action
mechanism: cell therapy/gene therapy/immunotherapy product
Disease: solid tumors (inoperable locally advanced or metastatic melanoma, and urothelial, head and neck, ovarian, non-small cell lung, esophageal, and gastric cancers expressing MAGE-A4)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This study will investigate the safety and tolerability of MAGE-A4?¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, or gastric tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. (NCT03132922)
Latest
news:
- • On May 16, 2017, Adaptimmune Therapeutics announced that it has initiated the first site for its MAGE-A4 SPEAR T-cell study in patients with multiple malignant solid tumors. This study is now open for enrollment. This is Adaptimmune’s third wholly-owned therapeutic candidate to enter clinical trials.
- • On January 9, 2017, Adaptimmune Therapeutics announced that the FDA has accepted its investigational new drug (IND) application for autologous genetically modified T-cells expressing an affinity optimized T-cell receptor (TCR) specific for MAGE-A4 in patients with multiple malignant solid tumors. Under this IND, Adaptimmune will initiate a Phase I, open-label, modified 3+3 dose escalation study of autologous T-cells genetically engineered with an affinity optimized MAGE-A4 TCR in HLA*02 positive patients with inoperable locally advanced or metastatic melanoma, and urothelial, head and neck, ovarian, non-small cell lung, esophageal, and gastric cancers expressing MAGE-A4. Patients will receive preconditioning with modified fludarabine and cyclophosphamide as used in the Company’s ongoing synovial sarcoma study. This multi-tumor study will enroll up to 32 patients.
Is
general: Yes
