Clinical Trials

Overview

We are conducting clinical trials with our four SPEAR T-cells therapies (ADP-A2M4, ADP-A2AFP, ADP-A2M4CD8, and ADP-A2M10) in ten cancers. The purpose of this section is to serve as an introduction for patients who might be interested in our current trials. Below is a list of the trials we are conducting with links to the clinicaltrials.gov pages, where you can find more details about each trial including participating clinical trial sites.

In each section, you will also find information about the various cancer types we are investigating, and details about participating in our trials.

In general, patients obtain access to investigational therapies prior to regulatory approval by participating in clinical trials. There may, however, be circumstances when patients with a serious or life-threatening illness have exhausted all available treatment options and are not eligible to participate in any appropriate clinical trials. In those cases, patients may be eligible for treatment with an investigational therapy through programs referred to as ‘Expanded Access Programs’ (EAPs) or ‘compassionate use’. Click here to read about our policy.

For more details on the technology, development, and product pipeline, please visit the corresponding pages on our site.

For patient inquiries, please contact patients@adaptimmune.com

Discuss with your doctor whether participating in a clinical trial is right for you.

SPEARHEAD-1 (ADP-A2M4)

This is a Phase 2, open-label, single arm clinical trial to evaluate the anti-tumor activity of ADP-A2M4 SPEAR T-cells in patients who are HLA-A*02 positive and have inoperable locally advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) expressing MAGE-A4.

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SPEARHEAD-2 (ADP-A2M4 in combination with pembrolizumab)

This is a Phase 2, single arm clinical trial to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 positive patients with recurrent or metastatic head and neck cancers expressing MAGE-A4.

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SURPASS (ADP-A2M4CD8)

This is a Phase 1, open-label, dose escalation clinical trial to evaluate the safety and anti-tumor activity of next-generation ADP-A2M4CD8 SPEAR T-cells in patients who are HLA-A*02 positive and have inoperable locally advanced urothelial, ovarian, esophageal, esophagogastric junction, gastric, non-small cell lung (NSCLC), or head and neck cancers, expressing MAGE-A4.

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SURPASS-2 (ADP-A2M4CD8)

This is a Phase 2, open-label, clinical trial to evaluate the safety and anti-tumor activity of ADP-A2M4CD8 SPEAR T-cells in HLA-A*02 patients with advanced esophageal or esophagogastric junction (EGJ) cancers expressing MAGE-A4.

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ADP-A2M4 Phase 1 clinical trial

This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of Adaptimmune's ADP-A2M4 therapeutic candidate in patients who are HLA-A*02 positive and have inoperable locally advanced or metastatic melanoma, urothelial cancer, head and neck cancers, ovarian cancer, non-small cell lung cancer (NSCLC), esophageal cancers, synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), and gastric cancers expressing MAGE-A4. The primary objective of the clinical trial is to evaluate the safety and tolerability of ADP-A2M4. Further details are available via the link below.

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Low-radiation Sub-study (ADP-A2M4)

This is a Phase 1, single-center sub-study to characterize safety and tolerability and assess anti-tumor activity of low dose radiation in combination with ADP-A2M4 across multiple tumor types. Up to 10 patients will be treated at MD Anderson Cancer Center. This is a sub-study of the ADP-A2M4 Phase 1 trial.

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ADP-A2AFP Phase 1 clinical trial

This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of Adaptimmune's ADP-A2AFP therapeutic candidate. The ongoing trial will include patients who have advanced hepatocellular carcinoma (liver cancer), which has grown or returned after being treated, and who are HLA-A*02 positive and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein. Patients who did not tolerate or refused other therapies may also participate. The primary objective of the clinical trial is to evaluate the safety and tolerability of ADP-A2AFP SPEAR T-cell therapy. Further details are available via the link below.

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ADP-A2M10 Non-Small Cell Lung Cancer clinical trial

Please note that this trial with ADP-A2M10 is now closed for enrollment. This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of Adaptimmune's ADP-A2M10 (MAGE-A10) therapeutic candidate in patients who are HLA-A*02 positive and have advanced (Stage IIIb or Stage IV) or recurrent non-small cell lung cancer (NSCLC) that expresses MAGE-A10. The primary objective of the clinical trial is to evaluate the safety and tolerability of ADP-A2M10 SPEAR T-cell therapy. Further details are available via the link below.

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ADP-A2M10 Triple Tumor clinical trial

Please note that this trial with ADP-A2M10 is now closed for enrollment. This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of Adaptimmune's ADP-A2M10 (MAGE-A10) therapeutic candidate in patients who are HLA-A*02 positive and have inoperable locally advanced or metastatic melanoma, urothelial cancer, or head and neck cancers that express MAGE-A10. The primary objective of the clinical trial is to evaluate the safety and tolerability of ADP-A2M10 SPEAR T- cell therapy. Further details are available via the link below.

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