Drugs / afamitresgene autoleucel
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03132922 | May 2017 → Dec 2022 overdue | esophageal cancer, gastric cancer, gastroesophageal cancer, head and neck cancer +6 | USWM CT, LLC | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05642455 | Sep 2023 → Oct 2026 expected | malignant peripheral nerve sheath tumor, neuroblastoma, osteosarcoma, synovial sarcoma | USWM CT, LLC | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04044768 | Aug 2019 → Aug 2021 overdue | myxoid liposarcoma, synovial sarcoma | USWM CT, LLC | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT06617572 Background | — | myxoid liposarcoma, synovial sarcoma | USWM CT, LLC | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | USWM, LLC (dba US WorldMeds) | Regulatory US WorldMeds® Receives Full U.S. FDA Approval of TECELRA® (afamitresgene autoleucel) with an Expanded Indication, Extending the First Approved Engineered T-Cell Therapy for a Solid Tumor to Children as Young as 12 usworldmeds.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | USWM, LLC (dba US WorldMeds) | US WorldMeds® Receives Full U.S. FDA Approval of TECELRA® (afamitresgene autoleucel) with an Expanded Indication, Extending the First Approved Engineered T-Cell Therapy for a Solid Tumor to Children as Young as 12 usworldmeds.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Afamitresgene autoleucel | “Afamitresgene autoleucel (afami-cel) is a human leukocyte antigen-restricted autologous T cell therapy targeting melanoma-associated antigen A4 (MAGE-A4), a cancer/testis...” PMID 36624315 ↗ Jan 2023 |
| Known as | ADP-A2M4 | “Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion” NCT04044768 ↗ |
| Known as | afami-cel | “Afamitresgene autoleucel (afami-cel) is a human leukocyte antigen-restricted autologous T cell therapy targeting melanoma-associated antigen A4 (MAGE-A4), a cancer/testis...” PMID 36624315 ↗ Jan 2023 |
| Known as | MAGE-A4c1032T | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802254 ↗ |
| Known as | TECELRA | “Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification” NCT06617572 ↗ |
| Modality | Cell therapy | “Afamitresgene autoleucel (afami-cel) is a human leukocyte antigen-restricted autologous T cell therapy” PMID 36624315 ↗ Jan 2023 |
| Route | Intravenous | “transduced by a single intravenous infusion” NCT04044768 ↗ |
| Target | MAGEA4 | “targeting melanoma-associated antigen A4 (MAGE-A4)” PMID 36624315 ↗ Jan 2023 |