Trial Search Results

MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC

This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and a tumor test positive for MAGE A10 protein expression (protein or gene). The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Adaptimmune

Intervention(s):

  • Biological: Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T

Phase:

Phase 1

Eligibility


Key Inclusion Criteria:

   1. Subject has histologically or cytologically confirmed diagnosis of advanced non-small
   cell lung cancer (stage IIIB or IV) or recurrent disease

   2. Subject has received at least one line of prior therapy

   3. Subjects with known epidermal growth factor receptor (EGFR) mutations or anaplastic
   lymphoma kinase receptor (ALK) or ROS1 gene rearrangements must have failed
   (progressive disease or unacceptable toxicity) at least one prior EGFR or ALK or ROS1
   tyrosine kinase inhibitor, respectively. Subject may have received PD-1 or PDL-1
   inhibitors and or chemotherapy. There is no limit on lines of prior anti-cancer
   therapy (a washout period applies for recent anti-cancer treatments).

   4. Subject has measurable disease according to RECIST v1.1 criteria prior to
   lymphodepletion.

   5. Subject is HLA-A*02:01 or HLA-A*02:06 positive.

   6. Subject's tumor (either an archival specimen or a fresh biopsy if archival tissue is
   unavailable) has been pathologically reviewed by a designated central laboratory
   confirming MAGE-A10 expression.

   7. Subject has an ECOG Performance Status 0-1 and anticipated life expectancy >6 months
   prior to apheresis and >3 months prior to lymphodepletion.

   8. Subject is ≥18 years of age

   9. Adequate organ function

Key Exclusion Criteria:

   1. Subject is HLA-A*02:05, HLA-B*15:01 and/or HLA-B*46:01 positive.

   2. History of chronic or recurrent (within the last year prior to enrollment) severe
   autoimmune or active immune-mediated disease requiring steroids or other
   immunosuppressive treatments.

   3. Subject has symptomatic CNS metastases. Subjects with prior history of symptomatic CNS
   metastasis must have received treatment and be neurologically stable for at least 1
   month prior to leukapheresis and lymphodepletion.

   4. Active malignancy besides NSCLC within 3 years prior to screening.

   5. Uncontrolled intercurrent illness including, but not limited to:

      - Ongoing or active infection;

      - Clinically significant cardiac disease

      - Inadequate pulmonary function

      - Interstitial lung disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jordan Preiss
650-723-1002
Recruiting