Clinical Trial 23553

• Overview

  Study Title:

  DENALI-1: A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod CAR T, in Heterozygous HLA A*02 Adults with Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA A*02 Expression.

  Objective:

  The primary objectives of Phase 1 are to evaluate the safety and tolerability of A2B395, and to determine the recommended Phase 2 dose (RP2D). The primary objective of Phase 2 is to evaluate the efficacy of A2B395.

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  A2B395 (); MESNA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A*02 by NGS (whenever possible from the primary site).
  • Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.
  • Received previous required therapy for the appropriate solid tumor disease as described in the protocol Has adequate organ function as described in the protocol.
  • ECOG performance status of 0 to 1.
  • Life expectancy of ≥3 months.
  • Willing to comply with study schedule of assessments including long-term safety follow-up.
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative.
  • Prior allogeneic stem cell transplant.
  • Prior solid organ transplant.
  • Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion.
  • Radiotherapy within 28 days of A2B395 infusion.
  • Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months.
  • Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated.
  • History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year.
  • Requires supplemental home oxygen.
  • Females of childbearing potential who are pregnant or breastfeeding.
  • Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395.
  • Additional criteria may apply.

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