Moffitt logo

Clinical Trials Search

Clinical Trial 19707

Cancer Type: Sarcoma
Interventions:MAGE-A4; MESNA; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Mihaela Druta

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase 1 Dose Escalation, Multi-Tumor Study To Assess The Safety, Tolerability And Antitumor Activity Of Genetically Engineered Mage-A4c1032t In Hla-A2+ Subjects With Mage-A4 Positive Tumors

Summary

Objective

Primary: To evaluate the safety and tolerability of autologous genetically modified T cells (MAGE-A4c1032T) in subjects with HLA-A*02 and MAGE-A4 positive inoperable locally advanced or metastatic tumors Secondary: To evaluate the anti-tumor activity of autologous genetically modified T cells (MAGE-A4c1032T) in HLA-A*02 subjects with MAGE-A4 positive inoperable locally advanced or metastatic tumors

Inclusion Criteria

  • 18 years of age or more at the time of signing the study informed consent.
  • Has histologically confirmed diagnosis of any one of the following cancers: urothelial cancer (transitional cell cancer of the bladder, ureter, urethra or renal pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC (squamous, adenosquamous, adenocarcinoma or large cell), esophageal (squamous and adenocarcinoma) or gastric cancer, synovial sarcoma or MRCLS.
  • Is HLA-A*02 positive and Participant's tumor shows expression of the MAGE-A4 RNA or protein.
  • Has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
  • Meets disease-specific requirements per protocol
  • Has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.

  • Exclusion Criteria

  • Is HLA-A*02:05 positive in either allele; Participant has HLA-A*02:07 as the sole HLA-A*02 allele (e.g., a Participant with HLA alleles A*02:04 and A*02:07 is eligible); or Participant has any A*02 null allele (designated with an "N", e.g., A*02:32N) as the sole HLA-A*02 allele
  • Is receiving excluded therapy/treatment per protocol
  • Has symptomatic CNS metastases.
  • Has any other active malignancy besides the tumor under study within 3 years prior to Screening. Participant has uncontrolled intercurrent illness.
  • Has active infection with HIV, HBV, HCV or HTLV
  • Is pregnant or breastfeeding.