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Also known as rQNestin, rQNestin34.5v.2
CAN-3110 · 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...
CAN-3110 is an investigational therapy being studied for the treatment of recurrent malignant glioma of the brain, including glioblastoma and related high-grade brain tumors. It is being developed for patients with recurrent disease and is not yet approved for commercial use.
CAN-3110 is being developed by Candel Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol CADL. The company is running the clinical program for this asset in recurrent malignant glioma.
CAN-3110 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program is evaluating the treatment in patients with recurrent malignant glioma of the brain.
CAN-3110 is being evaluated in the Phase 1 trial NCT03152318, titled A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2. The trial is active but not recruiting, has enrolled 62 patients, and is being conducted in the United States in adults 18 years and older.
Yes, CAN-3110 is also known as rQNestin, and the Phase 1 trial lists it as rQNestin34.5v.2. These names refer to the same investigational agent being studied in recurrent malignant glioma, so searches for either name point to the same Candel Therapeutics program.
Yes, CAN-3110 is a biomarker-selected therapy, meaning the clinical program enrolls patients based on a defined biomarker rather than an unselected population. The Phase 1 trial NCT03152318 is a controlled study in adults with recurrent malignant glioma and does not use randomization or double blinding.