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Clinical Trial 21589

Cancer Type: Immunotherapy
Study Type: Other
NCT#: NCT04981119

Phase: N/A
Principal Investigator: Kirtane, Kedar

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Overview

Study Title

BASECAMP-1: An Observational Study Obtaining Solid Tumor Tissue from Subjects with Primary Surgical Resection and Leukapheresis for CAR T-Cell Therapy Manufacturing

Summary

To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform leukapheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.

Objective

Primary Objectives: Subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of undergoing leukapheresis. Subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of undergoing leukapheresis. The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of undergoing leukapheresis. The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of undergoing leukapheresis. Subjects experiencing loss of heterozygosity of HLA-A*02. Secondary Objectives: Subjects who experience an adverse event (AE) related to leukapheresis. Subjects who experience a grade 4 toxicity related to leukapheresis. Exploratory Objectives: T-cell profiling of leukapheresis product. Biomarker analysis

Treatments

Therapies

Medications

Inclusion Criteria

Key Eligibility Criteria Part 1 Key Inclusion Criteria

  • Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years. Part 2 : Key Inclusion Criteria
  • Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.
  • Participants are germline HLA-A*02 heterozygous confirmed by HLA typing.
  • Primary tumor tissue showing LOH of HLA-A*02 by NGS testing.
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.
  • Other criteria may apply

  • Exclusion Criteria

    Part 1: Key Exclusion Criteria

  • History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
  • Prior allogeneic stem cell transplant.
  • Prior solid organ transplant. Part 2: Key Exclusion Criteria
  • History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
  • Prior allogeneic stem cell transplant.
  • Prior solid organ transplant.
  • Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned leukapheresis or 3 half-lives, whichever is shorter.
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).
  • Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.
  • In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.
  • Other criteria may apply

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