Thursday, October 24, 2019 4:49:00 PM
It was an open label, PhI trial, and 17 patients (under the age of 25) with advanced, high-risk CD19+ ALL were enrolled. Fourteen patients received lymphodepletion followed by the infusion of CAR T-cells (the product couldn't be generated for the remaining three).
Thirteen out of 14 patients developed cytokine release syndrome, which was generally mild (nine patients with Gr1, and four with Gr2). No severe (Gr3 or above) CRS was observed. Six had Gr1/2 neurotoxicity and one experienced Gr4 encephalopathy. One developed prolonged neutropenia, multiple infections, and Gr4 encephalopathy, and died from sepsis while in remission. Thirteen out of 14 patients developed prolonged B-cell aplasia.
At 30 days post infusion, 10 achieved a complete response. At 90 days, 12 of 14 had achieved a CR, one was alive with CD19+ disease, and one died due to progression of CD19+ disease. Six who achieved CR ultimately relapsed: 5 with CD19- and 1 with CD19+. In cases of CD19+ relapse/non-responding disease, anti-CAR-specific cytotoxic responses were detected, suggesting endogenous T-cell mediated rejection of CAR T-cells (not good). At a median follow-up of 14 months, 5 out of 14 (36%) patients remained in CR. Overall survival was 84% at 6 months and 63% at 12 months. Event-free survival was 63% and 46% at 6 and 12 months, respectively.
CAR T-cells exhibited mostly naive or central memory phenotypes and had a low level expression of PD-1 and TIM3. CAR T-cells underwent robust expansion in the periphery in 12 out of 14 patients, with a median time to peak expansion of 14 days. At peak expansion, a median of 41% of circulating T-cells were CAR T-cells. CAR T-cells contracted over time, but remained detectable in 11 out of 14 patients at last follow-up (up to 24 months for some patients). The median duration of persistence of CAR T-cells at data cutoff was 215 days. Peak expansion, exposure, persistence, and half-life were all higher than published data for an approved product.
Recent AUTL News
- Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO • GlobeNewswire Inc. • 04/24/2024 02:00:00 PM
- Autolus Therapeutics to Report First Quarter 2024 Financial Results and Host Conference Call on May 14, 2024 • GlobeNewswire Inc. • 04/23/2024 11:00:00 AM
- Autolus Therapeutics announces acceptance of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (B-ALL • GlobeNewswire Inc. • 04/02/2024 11:00:00 AM
- Autolus Therapeutics Announces Changes to its Board of Directors • GlobeNewswire Inc. • 04/01/2024 11:00:00 AM
- Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates • GlobeNewswire Inc. • 03/14/2024 11:00:00 AM
- Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site • GlobeNewswire Inc. • 03/12/2024 11:00:00 AM
- Autolus Therapeutics announces publication in Blood Cancer Journal • GlobeNewswire Inc. • 03/11/2024 11:00:00 AM
- Autolus Therapeutics to Report Full Year 2023 Financial Results and Business Updates on March 14, 2024 • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- Form D - Notice of Exempt Offering of Securities • Edgar (US Regulatory) • 02/23/2024 10:28:32 PM
- Autolus Therapeutics announces publication in Nature Communications • GlobeNewswire Inc. • 02/22/2024 12:00:00 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 02/21/2024 10:01:33 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 01:37:20 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/09/2024 10:15:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/08/2024 09:17:55 PM
- Autolus Announces Pricing of Underwritten Offering • GlobeNewswire Inc. • 02/08/2024 12:00:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/08/2024 11:06:00 AM
- BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs • GlobeNewswire Inc. • 02/08/2024 10:45:00 AM
- Form S-3ASR - Automatic shelf registration statement of securities of well-known seasoned issuers • Edgar (US Regulatory) • 02/08/2024 03:00:28 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/31/2024 09:10:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/26/2024 06:02:13 PM
- Autolus Therapeutics announces publication in ACS Chemical Biology • GlobeNewswire Inc. • 01/23/2024 12:00:00 PM
- Autolus Therapeutics Gets BLA Acceptance for Obecabtagene Autoleucel • Dow Jones News • 01/22/2024 12:54:00 PM
- Autolus Therapeutics announces acceptance of Biologics License Application for obecabtagene autoleucel (obe-cel) as a potential treatment for relapsed/refractory Adult B-cell Acute Lymphoblastic Leukemia (ALL) • GlobeNewswire Inc. • 01/22/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/10/2024 08:12:17 PM
- Autolus Therapeutics announces the appointment of Robert W. Azelby to its Board of Directors • GlobeNewswire Inc. • 01/10/2024 12:00:00 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM