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A Phase 2, Open-Label Evaluation of the Safety and Efficacy of CB-10-01, Transgenic Lymphocyte Immunization (TLI) Against Telomerase, as Adjuvant Therapy in Subjects With Stage III Melanoma

Phase 2
18 Years
Open (Enrolling)
Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma

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Trial Information

A Phase 2, Open-Label Evaluation of the Safety and Efficacy of CB-10-01, Transgenic Lymphocyte Immunization (TLI) Against Telomerase, as Adjuvant Therapy in Subjects With Stage III Melanoma

Inclusion Criteria:

- Male or female subjects ≥18 years of age and able to understand and give written
informed consent

- Women subjects of childbearing potential (WOCBP) and male subjects must be using an
effective method of contraception

- Histologic diagnosis of malignant melanoma:

- Melanoma primary completely resected with negative margins. Primary surgery
must be <8 weeks from leukapheresis procedure

- Stage IIIB or Stage IIIC according to the American Joint Committee on Cancer
(AJCC) Tumor-Node-Metastasis (TNM) criteria (Appendix 2) OR previously resected
Stage I or II melanoma that recurs as Stage IIIB or IIIC.

- HLA-A2 positive

- ECOG Performance Status of 0, 1 or 2 (Appendix 3)

- Adequate bone marrow, hepatic, and renal function:

- WBC ≥1500/μL

- ANC ≥1000/μL

- Platelets ≥100 × 103/μL

- Hemoglobin ≥9 g/dL

- Creatinine ≤2 ULN

- AST ≤2 ULN

- Bilirubin ≤2 ULN (except for subjects with Gilbert's Syndrome who must have a
total bilirubin <3.0 mg/mL)

- Negative screening tests for HIV, Hepatitis B and C

Exclusion Criteria:

- Female subjects, their partners and male subjects who are unwilling or unable to
practice abstinence or use a barrier method (condoms) during intercourse to minimize
the risk of exposure to the blood-borne transgene for the entire period of the study
and for up to 8 weeks after the last TLI infusion

- Known allergy to DMSO

- Any malignancy from which the subject has been disease-free for less than 5 years,
with the exception of adequately treated and cured basal or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix

- Primary ocular or mucosal melanoma

- Autoimmune disease: subjects with a documented history of symptomatic autoimmune
disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma],
systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis])
that has or may require systemic therapy

- Concomitant therapy with any anticancer agent; immunosuppressive agents; other
investigational therapies; or chronic use of systemic corticosteroids (used in the
management of cancer or non cancer-related illnesses). Replacement doses of
corticosteroids are allowed in subjects with adrenal insufficiency

- Prior biologic therapy for melanoma

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint will be the percentage of subjects who have no recurrence of metastatic melanoma at 24 months from the time of primary surgery.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Gregory Daniels, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

July 2014

Related Keywords:

  • Stage IIIB Skin Melanoma
  • Stage IIIC Skin Melanoma
  • Stage III Melanoma
  • Melanoma
  • TLI
  • Transgenic Lymphocyte Immunization
  • CB-10-01-02
  • Melanoma
  • Skin Neoplasms



John Wayne Cancer Institute Santa Monica, California  90404
University of California San Diego La Jolla, California  92093
City of Hope Duarte, California  91010
University of California Los Angeles Los Angeles, California  90095-6951
Northern California Melanoma Center San Francisco, California  94109