FDA Grants Fast-Track Status to CAR-T Therapy
The FDA has granted fast-track designation to SynKIR-110, a mesothelin-targeting CAR-T cell therapy being developed by Nkarta for patients with advanced mesothelioma and other mesothelin-expressing solid tumors.
Fast-track designation is intended to expedite the development and review of treatments for serious conditions with unmet medical needs. For mesothelioma patients who have exhausted standard options, this designation represents progress toward potentially new treatment approaches.
What Is SynKIR-110?
SynKIR-110 is an autologous CAR-T cell therapy, meaning it uses a patient’s own T-cells that have been genetically modified to recognize and attack cancer cells.
Key features:
- Target: Mesothelin (MSLN), a protein highly expressed on mesothelioma cells
- Technology: Novel KIR-CAR (Killer Immunoglobulin-like Receptor CAR) design
- Approach: Enhanced T-cell recognition and killing of mesothelin-expressing tumors
The KIR-CAR design differs from traditional CARs and may provide advantages in recognizing and eliminating cancer cells.
The STAR-101 Trial
The Phase 1 STAR-101 trial is evaluating SynKIR-110 in patients with:
- Malignant mesothelioma
- Ovarian cancer
- Primary peritoneal cancer
Participating Centers
The trial is recruiting at leading cancer institutions:
- MD Anderson Cancer Center (Houston, TX)
- University of Pennsylvania (Philadelphia, PA)
- University of Wisconsin Carbone Cancer Center (Madison, WI)
- University of Kansas Cancer Center (Westwood, KS)
Eligibility
The first-in-human study is evaluating safety and dosing in patients with:
- HLA-A*02 positive status
- Advanced mesothelin-expressing solid tumors
- Previous standard treatment
What Fast-Track Means
FDA fast-track designation provides:
- More frequent meetings with FDA
- Eligibility for priority review
- Potential for rolling review (FDA can review sections as completed)
- Accelerated approval pathway if appropriate
What it does NOT mean:
- Not a guarantee of approval
- Not evidence that the therapy works
- Early-stage trials must still demonstrate safety and efficacy
Search ClinicalTrials.gov for “mesothelioma CAR-T,” contact participating centers (MD Anderson, Penn, Wisconsin, Kansas) directly, discuss eligibility with your oncologist, or call the NCI Cancer Information Service: 1-800-4-CANCER.
Why This Matters for Mesothelioma
CAR-T therapy has achieved remarkable success in blood cancers, but solid tumors like mesothelioma have been more challenging. The fast-track designation for SynKIR-110 signals:
- Recognition of unmet need in mesothelioma treatment
- Progress in CAR-T technology for solid tumors
- Potential for new treatment options beyond checkpoint inhibitors
Current CAR-T Trials for Mesothelioma
SynKIR-110 is one of several CAR-T approaches being studied:
| Trial | Target | Status |
|---|---|---|
| SynKIR-110 (STAR-101) | Mesothelin | Recruiting |
| A2B694 (EVEREST-2) | Mesothelin | Recruiting |
| Tmod CAR-T | Mesothelin | Phase 1/2 |
How to Learn More
Patients interested in CAR-T trials can:
- Search ClinicalTrials.gov for “mesothelioma CAR-T”
- Contact participating centers directly
- Discuss eligibility with their oncologist
- Call the NCI Cancer Information Service: 1-800-4-CANCER
Looking Ahead
Results from the STAR-101 trial will help determine whether SynKIR-110 can provide meaningful benefit for mesothelioma patients. If Phase 1 shows acceptable safety and early efficacy signals, larger trials would follow.
For patients who have not responded to chemotherapy or immunotherapy, CAR-T represents a fundamentally different approach that researchers hope will provide new options.
What is SynKIR-110?▼
SynKIR-110 is an autologous CAR-T cell therapy that uses a patient’s own T-cells, genetically modified to recognize and attack mesothelin—a protein highly expressed on mesothelioma cells. It uses a novel KIR-CAR design that may provide advantages over traditional CARs.
What does FDA fast-track designation mean?▼
Fast-track provides more frequent FDA meetings, eligibility for priority review, and potential rolling review. However, it’s not a guarantee of approval or evidence the therapy works—early-stage trials must still demonstrate safety and efficacy.
Who can participate in the STAR-101 trial?▼
The Phase 1 trial recruits patients with HLA-A*02 positive status, advanced mesothelin-expressing solid tumors (including mesothelioma, ovarian cancer, peritoneal cancer), and previous standard treatment. Participating centers include MD Anderson, Penn, Wisconsin, and Kansas.
Why is CAR-T difficult for solid tumors?▼
CAR-T has achieved remarkable success in blood cancers but solid tumors like mesothelioma have been more challenging. The fast-track designation signals progress in adapting CAR-T technology for solid tumors and recognition of mesothelioma’s unmet need.