Canine Canine Personalized mRNA Immunotherapy IIT — Study Details & Eligibility
Who can enroll, how the process works, and what it costs — read before you apply
The canine personalized mRNA immunotherapy IIT study is an investigator-initiated, multi-center translational study sponsored and funded by PETcura, with technical support from research partners, exploring the safety, feasibility, and preliminary efficacy of custom mRNA immune formulations for dogs with malignant tumors. This is an exploratory study — not a commercially approved veterinary product.
Study objectives
- Ultra-deep RNA sequencing (≥50G) to identify canine tumor-specific neoantigens (mutations, gene fusions, alternative splicing)
- Custom mRNA-LNP formulation for each dog
- Induce neoantigen-specific CD8⁺ T-cell responses
- Validate an 8-dose schedule (5 weekly priming + rest + 3 triweekly boosting)
- Standardized baseline, serial blood monitoring, and final comprehensive assessment
Eligibility (all required)
- Pathology: histologically or cytologically confirmed canine malignancy (solid tumors and lymphoma; excluding T-cell lymphoma and brain tumors)
- Sample availability: fresh tumor tissue + paired normal tissue collectable during surgery
- Health: adequate overall condition and blood chemistry (ALT/AST < 3×ULN, creatinine < 2×ULN, Hb > 80 g/L)
- LNP tolerance assessment: passes a screening injection of the same LNP system (1 hour in-clinic observation, no systemic allergic reaction) — mandatory
- Informed consent: owner fully informed, signed, and able to comply with monitoring and blood sampling
Exclusions: T-cell lymphoma, brain tumors; chemotherapy/radiation/high-dose corticosteroids within 2 weeks; severe infection; autoimmune disease or confirmed immunodeficiency; pregnancy/lactation; expected survival < 6 months.
Treatment timeline
| Stage | Content | Timing |
|---|---|---|
| Enrollment | Pathology + LNP tolerance + health/blood + consent | Before/after surgery |
| T0 Sampling | Tumor + normal tissue collected during surgery, cold chain | Surgery day |
| T1–T6 Manufacturing | RNA sequencing (~2 weeks) → neoantigen analysis & sequence design → synthesis, LNP encapsulation, QC release | ~7–9 weeks from sampling |
| D0–D28 | Priming: 5 doses weekly (IM lateral thigh, fixed 20 µg/0.5 mL) | 5 weeks |
| D29–D41 | Lymph node rest period | 14 days |
| D42–D84 | Boosting: 3 doses triweekly | 6 weeks |
| D85–D99 | Final comprehensive assessment (safety + imaging/caliper) | — |
| Long-term | Regular follow-up (first imaging 1–2 months after treatment) | Ongoing |
Safety design
- Tolerance screening: LNP intramuscular tolerance assessment before enrollment; positive (systemic allergic reaction) → excluded after one test
- Monitoring: blood work before every dose; temperature, mentation, appetite recorded
- Emergency readiness: clinics must be equipped with resuscitation cart (epinephrine, antihistamines, dexamethasone); ≥1 hour observation after each injection
- AE management: mild → record/observe; moderate → pause next dose; severe/SAE → stop, emergency care, report to sponsor
- Restriction: no high-dose corticosteroids from D0–D84 (would compromise immune activation), except emergency use
Fallback delivery
Every case that completes RNA sequencing — whether or not neoantigens are found — receives a targeted drug guidance report based on the tumor's molecular profile (reference for your veterinarian; not a prescription).
Data & privacy
Case data are used for internal study analysis and periodic review; with owner authorization, de-identified data may be used in academic publications, conference reports, and study communications. Participating veterinarians are credited as co-investigators in future publications.
Learn more: Owner FAQ · Participating cities · How it works