Drugs / Obecabtagene autoleucel
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Aucatzyl | — | 2025-07-17 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07139743 | Aug 2025 → Aug 2029 expected | multiple sclerosis | Autolus Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT06333483 | Feb 2024 → Sep 2027 expected | systemic lupus erythematosus | Autolus Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT06173518 | Nov 2023 → Nov 2027 expected | B-cell acute lymphoblastic leukemia, aggressive B-cell non-Hodgkin lymphoma | Autolus Limited | Recruiting | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT04404660 | Jun 2020 → Jun 2029 expected | B-cell acute lymphoblastic leukemia | Autolus Limited | Active not recruiting | Met primary |
| Phase 23 trials | ||||||
| Phase 2 | NCT07400029 | Feb 2026 → Feb 2029 expected | acute lymphoblastic leukemia | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07053800 | Jan 2026 → Aug 2028 expected | lupus nephritis | Autolus Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT07053059 | Aug 2025 → May 2028 expected | acute lymphoblastic leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06799221 | — | B-cell acute lymphoblastic leukemia, adult acute lymphoblastic leukemia | Autolus Limited | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-12-07 | Adaptive Biotechnologies | Results Adaptive Biotechnologies Announces New Data at the 66th ASH Annual Meeting Highlighting Advances in MRD Testing with clonoSEQ® and Its Impact on Blood Cancer Treatment Decisions adaptivebiotech.com ↗
Data from the FELIX study indicate that achieving deep molecular remission, defined as MRD levels below 10⁻⁶, correlates with improved outcomes in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treated with obecabtagene autoleucel. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-12-07 | Adaptive Biotechnologies | Adaptive Biotechnologies Announces New Data at the 66th ASH Annual Meeting Highlighting Advances in MRD Testing with clonoSEQ® and Its Impact on Blood Cancer Treatment Decisions adaptivebiotech.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | obecabtagene autoleucel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06799221 ↗ |
| Known as | AUTO1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04404660 ↗ |
| Known as | obe-cel | “Out-of-specification (OOS) obecabtagene autoleucel (obe-cel) given as a split-dose infusion based on tumor burden assessment at lymphodepletion according to the United States...” NCT06799221 ↗4“The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy.” NCT07053059 ↗ “This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19” NCT06333483 ↗ “Obecabtagene autoleucel (obe-cel) given as a single infusion” NCT07053800 ↗ “Obecabtagene autoleucel (obe-cel)” NCT07139743 ↗ |
| Modality | Cell therapy | “autologous T cells engineered with a chimeric antigen receptor (CAR)” NCT06173518 ↗ |
| Route | Intravenous | “obe-cel administered intravenously” NCT06173518 ↗ |
| Target | CD19 | “CAR targeting cluster of differentiation (CD)19” NCT06173518 ↗ |