🏛️ Verified NIH Record • Updated 2026-07-07

Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors (NCT06651593)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (19 items).

Location: Md Anderson Cancer Center — Houston, Texas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
  • Participants who are pregnant or breastfeeding.
  • Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation. Inhaled or topical steroids, and adrenal replacement steroid doses 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  • Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
  • Participants with acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be excluded. Participants with chronic HBV or HCV with undetectable viral load will be eligible.
  • Previous solid organ or allogeneic HSCT.
  • Known brain or leptomeningeal metastases.
  • Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
  • Unresolved toxicities from prior therapy (defined as having not resolved to :51 Grade or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and :5 Grade 2 peripheral neuropathy.
  • Participants who have previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required permanent discontinuation or systemic immunosuppression due to irAEs (Cohort 1 only).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Md Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 563-3885

Email: anaing@mdanderson.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Solid Tumors clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗