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rQNestin · 1 trial · 14 indications
The primary objective is to determine the maximum tolerated dose of rQNestin34.5v.2 injected into recurrent malignant gliomas, with or without previous immunomodulation with cyclophosphamide.
| Arm | Type | Description |
|---|---|---|
| Arm A- rQNestin | EXPERIMENTAL | Arm A is rQNestin34.5v.2 treatment This study follows a standard 3+3 dose escalation design. Participants will not enroll to Arm B until the MTD or HTD has been met for Arm A. * Subjects with presumed radiologic evidence of recurrent malignant glioma will undergo stereotactic biopsy under monitored general or local anesthesia. Evidence of recurrent high grade or malignant must be found on frozen section for the person to receive administration of the agent. * rQNestin34.5v.2 Indicated dose as per cohort, Intratumor administration during surgery, single dose |
| Arm B- rQNestin+CPA | EXPERIMENTAL | Arm B is rQNestin34.5v.2 treatment with Cyclophosphamide (CPA) pre-treatment This study follows a standard 3+3 dose escalation design. Participants will not enroll to Arm B until the MTD or HTD has been met for Arm A. * Cyclophosphamide one intravenous injection 2 days prior to procedure. * Subjects with presumed radiologic evidence of recurrent malignant glioma will undergo stereotactic biopsy under monitored general or local anesthesia. Evidence of recurrent high grade or malignant must be found on frozen section for the person to receive administration of the agent. * rQNestin34.5v.2 Indicated dose as per cohort, Intratumor administration during surgery, single dose |
| Arm C- Multiple Dose rQNestin | EXPERIMENTAL | Arm C includes up to 6 intratumoral repeated doses of rQNestin34.5v.2, first in a cohort receiving 10\^8 pfus per time point, followed by a cohort receiving 10\^9 or 10\^7 pfus per time point. * Arm C adds 2 cohorts of 12 subjects in an open-label clinical trial of rQNestin34.5v.2 administered at two dose levels * The injections are planned for days 0, 15, 30, 60, 90, and 120 * Subjects with presumed radiologic evidence of recurrent malignant glioma will undergo stereotactic biopsy under monitored general or local anesthesia. Evidence of recurrent high grade or malignant must be found on frozen section for the person to receive administration of the agent. |
| Name | Type | Description |
|---|---|---|
| rQNestin | DRUG | rQNestin is an oncolytic viral vector. It is administered via intratumoral injection during biopsy surgery. |
| Cyclophosphamide | DRUG | Cyclophosphamide is an immunomodulating agent. It is administered intravenously in a single dose 2 days (+/- 6 hrs) before surgery. |
| Stereotactic biopsy | PROCEDURE | In both arms, subjects will undergo standard of care stereotactic biopsy in the intraoperative MRI operating room. The stereotactic needle will be placed stereotactically into the tumor bed using intraoperative MRI guidance to collect the biopsy, and again to administer the rQNestin oncolytic virus. |
Inclusion Criteria: * Frozen biopsy consistent with glioma by neuropathologist at the time of the first surgery in this longitudinal trial. Biopsy confirmation of glioma or infiltrative glioma at time of surgery will be acceptable, provided the subject has prior pathology confirmation of IDH wild-t...
rQNestin is an investigational therapy being studied for the treatment of recurrent malignant glioma of the brain, including conditions such as glioblastoma, astrocytoma, oligodendroglioma, and ependymoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.
rQNestin is being developed by Candel Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CADL. The company is conducting clinical trials to evaluate the safety and efficacy of rQNestin in patients with recurrent malignant glioma.
rQNestin is currently in Phase 1 clinical development. It is an investigational drug being studied in a single active clinical trial for recurrent malignant glioma. The drug is not yet approved by the FDA and remains in the early stages of clinical testing.
rQNestin is being evaluated in a Phase 1 clinical trial with the identifier NCT03152318, titled 'A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2'. The trial is active but not recruiting, with an estimated enrollment of 62 participants in the United States.
Yes, rQNestin is also known as rQNestin34.5v.2. The clinical trial NCT03152318 uses the name rQNestin34.5v.2 to refer to the same investigational drug being studied for recurrent malignant glioma.