Clinical Trials

Overview

We are enrolling patients in our clinical trials with two SPEAR T-cells therapies (afamicel and ADP-A2M4CD8) in multiple solid tumor indications. 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 (afamitresgene autoleucel ‘afami-cel’; formerly 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. Enrollment for Cohort 1 is now closed, enrolment of Cohort 2 is still open.

View Clinical Trial

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.

View Clinical Trial

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.

View Clinical Trial

afami-cel Phase 1 clinical trial

This was a Phase 1, open-label, dose-escalation clinical trial designed to evaluate the safety and anti-tumor activity of afami-cel in patients who were HLA-A*02 positive and had 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 was to evaluate the safety and tolerability of afami-cel. Further details are available via the link below.

This trial is now closed for enrollment.

View Clinical Trial

Low-radiation Sub-study (afami-cel)

This was a Phase 1, single-center sub-study to characterize safety and tolerability and assess anti-tumor activity of low dose radiation in combination with afami-cel across multiple tumor types. Up to 10 patients were treated at MD Anderson Cancer Center. This was a sub-study of the afami-cel Phase 1 trial. This trial is now closed for enrollment.

View Clinical Trial

SPEARHEAD-2 (afami-cel in combination with pembrolizumab)

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

View Clinical Trial

ADP-A2AFP Phase 1 clinical trial

This was 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 trial included patients who had advanced hepatocellular carcinoma (liver cancer), which had grown or returned after being treated, and who were HLA-A*02 positive and had adequate AFP protein in blood or tumor, and whose noncancerous liver tissue had very little AFP protein. Patients who did not tolerate or refused other therapies could have also participated. The primary objective of the clinical trial was to evaluate the safety and tolerability of ADP-A2AFP SPEAR T-cell therapy.

This trial has ceased enrollment.

View Clinical Trial

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.

View Clinical Trial

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.

View Clinical Trial