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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 InstituteSanta Monica, California  90404
University of California San DiegoLa Jolla, California  92093
City of HopeDuarte, California  91010
University of California Los AngelesLos Angeles, California  90095-6951
Northern California Melanoma CenterSan Francisco, California  94109