CT Antigen TCR-Engineered T Cells for Myeloma

• Status: Terminated
• Trial end date: 2018-04-09
• Target enrollment: 0
• Participant gender: All

Summary

This study will enroll patients with multiple myeloma who have received prior therapy for their disease but their disease has progressed or relapsed.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adaptimmune

Criteria

Inclusion Criteria:

• 1. Written informed consent must be obtained from all patients before entry into the study

2. Patients must have a diagnosis of myeloma (see Appendix A for diagnostic criteria).

3. Patients must have progressive or active disease following prior therapy for their myeloma which:

1. includes an IMiD and proteasome inhibitor as separate lines or a combined line of therapy

2. May include prior auto-SCT but not prior allo-SCT

Patients who have failed second or third line therapy and beyond, such as DPACE, and who are experiencing a partial response rather than progressive disease are also eligible.

4. Patients must have measurable disease on study entry. Measurable disease may include quantifiable or detectable levels of serum or urine paraprotein. For patients with minimally secretory disease on study entry, serum free kappa or lambda light chain levels, or the serum free light chain ratio may be measured and used for disease monitoring if abnormal.

5. Patients must be HLA-A201 as determined by a CLIA certified (or equivalent) clinical laboratory. (This determination will be made under a pre-enrollment screening ICF)

6. Patients must have confirmed expression of NY-ESO-1 and/or LAGE-1 by RT-PCR, immunohistochemistry or quantigene analysis. (This determination will be made under a pre-enrollment screening ICF)

Exclusion Criteria:

• 1. Pregnant or nursing females 2. HIV or HTLV-1/2 seropositivity 3. Known history of myelodysplasia 4. Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).

5. Active Infection with HBV or HCV

• Active hepatitis B infection as determined by test for hepatitis B surface antigen.

• Active hepatitis C. Patients will be screened for HCV antibody. If the HCV antibody is positive, a screening HCV RNA by any RT PCR or bDNA assay must be performed at screening by a local laboratory with a CLIA certification or its equivalent. Eligibility will be determined based on a negative screening value. The test is not required if documentation of a negative result of a HCV RNA test performed within 60 days prior to screening is provided.

6. Prior allogeneic transplant 7. History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.

8. Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.

9. Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study. The specific type of stress test will be selected at the PI's discretion.

10. Active bacterial or systemic viral or fungal infections.