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Table 4 Gene Therapy Clinical Trials Conducted at HFH Using Externally Developed Products

From: Oncolytic virus-based suicide gene therapy for cancer treatment: a perspective of the clinical trials conducted at Henry Ford Health

ClinicalTrials.gov Identifier

Product used/Treatment

Cancer

Statusa

Sponsor

Remarks

NCT04180215

HB-201 and HB-202: Replicating live-attenuated arenavirus vectors expressing HPV16 E6/E7 fusion protein

Head and Neck Squamous Cell Carcinoma and other solid tumors

Phase 1/ 2:

Recruiting (n = 200)

Hookipa Biotech GmbH

HB-201 monotherapy and HB-201 and HB-202 alternating two-vector therapy were well tolerated. HB-201 and HB-202 alternating two-vector therapy showed superior immune and more robust antitumor response compared to monotherapy

NCT03491683

DNA medicines (INO-5401 and INO-9012) with programmed death-1 (PD-1) protein targeting antibody (Cemiplimab) and chemo-radiotherapy

Glioblastoma (GBM)

Phase 1/2: Active, not recruiting (n = 52)

Inovio Pharmaceuticals

The primary outcome of the trial will study percentage of participants with Adverse Events at 0–30 days, 6 months and up to 24 months after the last dose of study treatment

NCT00676507

Lucanixâ„¢ vaccine therapy

Advanced Non-small Cell Lung Cancer (NSCLC)

Phase 3: Completed (n = 532)

NovaRx Corporation

The vaccine was well tolerated with no difference in the survival and PFS of patients in the two groups. However, an improved survival in Lucanix™ treated group was suggested in patients randomized within 12 weeks after the front- line chemotherapy was complete and in patients who had received radiation prior to vaccine treatment

NCT00050388

Allovectin-7®

head and neck cancer

Phase 3: Completed

Vical

Despite exhibiting safety and well tolerability with partial or complete tumor response in 33% patients in phase 1 and 2 trials, phase 3 trials failed to achieve their primary and secondary outcomes of tumor response and overall survival compared to chemotherapy in metastatic malignant melanoma patients

NCT01156584

Toca 511 or vocimagene amiretrorepvec: a nonlytic replicating γ-retroviral vector that encode for an optimized yCD transgene

Grade III/IV Gliomas

Phase 1: Completed (n = 54)

Tocagen Inc

A subgroup with both isocitrate dehydrogenase 1 (IDH1) mutant and wild-type tumors was identified for the follow up phase 3 study. This subgroup showed 21.7% durable response rate and follow-up for responders for median duration was 35.7 + months. After 33.9 + to 52.2 + months of administration of Toca 511, all responders were alive and remained in response, indicating a positive correlation between durable response and overall survival

NCT01156584

Toca 511

Recurrent high-grade glioma (rHGG)

Phase 1: Completed (n = 54)

Tocagen Inc

Depending on the group, patients were given Toca 511 intratumorally via transcranial injection or intravenously daily for 3 and 5 days. 3 to 4 weeks after Toca 511 administration, Toca FC was given and repeated approximately after every 6 weeks until end of study. All the patients after the end of the study were eligible to enroll in a long-term continuation protocol, which enabled additional dosing with Toca FC and permitted the long-term safety and survival data to be collected

NCT02414165

Toca 511 and Toca FC treatment vs lomustine or temozolomide or bevacizumab

Glioblastoma Multiforme or Anaplastic Astrocytoma

Phase 2/3: Terminated (n = 403)

Tocagen Inc

Toca 511 and Toca FC treatment did not show better show better efficacy than the standard of care treatment used in the study. This trial was subsequently terminated by Tocagen Inc

  1. aStatus as on 12/6/2022 based on clinicaltrials.gov