Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome

Opsona Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myelodysplastic Syndrome

Treatments: Drug: OPN-305

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03337451

OPN-305-110

Details and patient eligibility

About

This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of the OPN-305-106 study
• Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.
• Provide written informed consent for the follow up protocol.

Exclusion criteria

• Refusal to provide written informed consent
• Withdrawal from the OPN-305-106 study prior to the final EOT visit
• Plan to be included into another interventional investigational study.
• Progression of disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

OPN-305

Experimental group

Treatment:

Drug: OPN-305