Using a modified virus to treat patients with T-cell lymphoma
MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell Neoplasms
This study is testing a modified virus combined with immunotherapy to see if it can safely treat patients with different types of T-cell lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | IPILIMUMAB, CEMIPLIMAB, Chemotherapy, Immunotherapy, ipilmumab |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT06508463 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and optimal dosage of a modified vesicular stomatitis virus (VSV-hIFNβ-NIS) combined with immunotherapy agents ipilimumab and cemiplimab in patients with various forms of T-cell lymphoma. The study aims to determine the maximum tolerated dose while monitoring side effects and assessing the virus's ability to selectively target and kill cancer cells. Patients will undergo imaging scans and may have biopsies to evaluate treatment response throughout the study. Follow-up will occur for up to one year after treatment completion to monitor for disease progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed peripheral T-cell lymphoma or specific histologies such as anaplastic large cell lymphoma and mycosis fungoides.
Not a fit: Patients with active liver disease beyond Child Pugh class A or those with other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with relapsed or refractory T-cell lymphoma.
How similar studies have performed: While the use of oncolytic viruses in cancer treatment is an emerging field, this specific combination of VSV with immunotherapy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years * Relapsed or refractory: * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2 times upper limit of normal (ULN) (obtained =\< 15 days prior to registration) * Creatinine =\< 2.0 mg/dL (obtained =\< 15 days prior to registration) * Direct bilirubin =\< 1.5 x ULN (obtained =\< 15 days prior to registration) * International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 15 days prior to registration) * If baseline liver disease, Child Pugh score not exceeding class A (obtained =\< 15 days prior to registration) * Negative pregnancy test for persons of child-bearing potential (obtained =\< 15 days prior to registration) * FOR T-Cell Lymphoma (TCL)/B-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) \>= 1,000/microliter (μL) (obtained =\< 14 days prior to registration) * FOR TCL/BCL ONLY: Platelets \>= 100,000/μL (obtained =\< 14 days prior to registration) * FOR TCL/BCL ONLY: Hemoglobin \>= 8.5 g/dl (obtained =\< 14 days prior to registration) * FOR TCL/BCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \> 2 cm or tumor cells in the blood \> 5 x 10\^9/L; NOTE: skin lesions can be used if the area is \> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record * Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory * Ability to provide written informed consent * Willingness to return to Mayo Clinic for follow-up * Life expectancy \>= 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Willing to provide mandatory biological specimens for research purposes Exclusion Criteria: * Availability of and patient acceptance of curative therapy * Uncontrolled infection * Active tuberculosis or hepatitis, or chronic hepatitis * Any of the following prior therapies: * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\< 2 weeks prior to registration * Immunotherapy (monoclonal antibodies) =\< 4 weeks prior to registration * Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4 half-lives of the last dose of the agent * New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \[atrial fibrillation or supraventricular tachycardia (SVT)\] * Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated) * Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \[FDA\] approved indication and in the context of a research investigation); * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritis and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard) * Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant women or women of reproductive ability who are unwilling to use effective contraception * Nursing women * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment * ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH IPILIMUMAB AND CEMIPLIMAB) ONLY: * Diagnosis of AML * Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL) * Hypersensitivity to ipilimumab or its excipients
Where this trial is running
Scottsdale, Arizona and 1 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Kah Whye Peng, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.