Delving into the Latest Updates on Resecabtagene Autoleucel with Synapse

RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Regenerative Medicine Advanced Therapy (United States), Rare Pediatric Disease (United States)

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Structure/Sequence

Sequence Code 1292316171

Source: *****

Author: Awan, Farrukh ; Werner, Mallorie ; Zhou, Xiaolong ; Stadanlick, Jason ; Basu, Samik ; Chang, David ; Ishikawa, Larissa ; Thompson, Daniel ; Ellis, Alexandra ; Maverakis, Emanual ; Goldenberg, Jessica ; Abedi, Mehrdad ; Brieva, Joaquin ; Williams, Jazmean ; Cicarelli, Justin ; Nunez, Daniel ; Bass, Naomi ; Toreki, Amanda ; Impagliazzo, Angelina ; Volkov, Jenell ; Vorndran, Zachary ; Kobulsky, Danielle ; Choudhary, Gaurav S. ; Furmanak, Thomas ; Braccia, Domenick ; Binder, Gwendolyn K. ; Lam, Quynh ; Dominguez, Arturo ; Kresa-Reahl, Kiren ; Flanagan, Steve ; Tummala, Raj ; Hadi-Nezhad, Fatemeh ; Schreiber, Candice

Abstract:

Lymphodepleting preconditioning (LD) is essential for the efficacy of chimeric antigen receptor (CAR) T-cell therapy in hematologic malignancies. However, in the setting of autoimmune diseases (ADs), the contribution of LD for efficacy is unclear. Here, we report on the early safety, efficacy, and correlative data of the first 4 patients with pemphigus vulgaris (PV) who received resecabtagene autoleucel (rese-cel), a fully human CD19 CAR T-cell therapy, without LD in the RESET-PV trial, a substudy of the DesCAARTes trial. Following infusion, pemphigus disease area index scores improved significantly in all patients. A favorable safety profile was observed, with a single episode of grade 1 cytokine release syndrome. Immune effector cell–associated neurotoxicity was not observed. Rese-cel expansion was similar in patients with PV compared with other rese-cel–treated patients with AD who received LD. B-cell depletion was observed in all patients with PV, with 3 of 4 patients achieving B-cell aplasia. Elevations in serum B-cell activating factor (BAFF) level were observed, with 3 of 4 patients achieving levels within the lowest end of the range exhibited in rese-cel–treated patients with AD who received LD. PV autoantibodies decreased in 2 of 4 patients. These preliminary data suggest that LD may be dispensable for humanized CAR T-cell efficacy in patients with AD. This trial was registered at www.clinicaltrials.gov as NCT04422912.

01 Mar 2026·Molecular Therapy Advances

Case study of resecabtagene autoleucel in a subject with diffuse cutaneous systemic sclerosis treated in the RESET-SSc trial

Article

Author: Binder, Gwendolyn ; Basu, Samik ; Cai, Yuli ; Chang, David ; Nezhad, Fatemeh ; Ellis, Alexandra ; Kobulsky, Danielle ; Tsoi, Lam C ; Williams, Jazmean ; Ross, Charles ; Cicarelli, Justin ; Ishikawa, Larissa ; Bogle, Rachael ; Rivera, Tania Gonzalez ; Volkov, Jenell R ; Schmitt, Chris ; Little, Courtney ; Nunez, Daniel ; Dey, Poulami ; Ghosh, Monalisa ; Thompson, Daniel ; Furmanak, Thomas ; Braccia, Dominick ; Lam, Quynh ; Flannagan, Steve ; Tsou, Pei-Suen ; Gudjonsson, Johann E ; Werner, Mallorie ; Vorndran, Zachary ; Khanna, Dinesh ; Tummala, Raj ; Stadanlick, Jason ; Zahn, Carleigh ; Fox, Jennifer

Under compassionate use, CAR T cells have elicited durable remissions in patients with refractory systemic sclerosis (SSc). Here, we report on the safety, efficacy, and correlative data of the first SSc subject treated with a fully human CD19-CART cell therapy (resecabtagene autoleucel) in the RESET-SSc trial (NCT06328777). Nine days post-infusion, the subject experienced a brief grade 2 episode of cytokine release syndrome that resolved promptly with intravenous hydration and indomethacin. Immune-effector-cell-associated neurotoxicity syndrome was not observed. Seven days post-infusion, the subject experienced a brief grade 4 episode of neutropenia that resolved rapidly with a single dose of colony-stimulating factor. Despite discontinuation of all immunosuppressants since infusion, over the 9-month period post-infusion, the subject's skin thickness decreased, pulmonary function improved, and nailfold vasculature improvement was observed. Following infusion, B cells were depleted both in the periphery and within secondary lymphoid tissue. B cell aplasia was observed by day 13 post-infusion. Furthermore, serum BAFF was highly elevated. B cell repopulation began 8 weeks post-infusion, with cells exhibiting a transitional naive phenotype. Autoantibodies to RNA polymerase III decreased to undetectable levels. The infusion product consisted of predominantly CD4⁺ T cells, and both CD4⁺ and CD8⁺ populations had similar in vitro activity. Post-infusion, rese-cel expansion peaked at 13 days. These data detail the safety, efficacy, and pharmacodynamics of rese-cel in the first SSc subject.

01 Nov 2024·MOLECULAR THERAPY

Case study of CD19 CAR T therapy in a subject with immune-mediate necrotizing myopathy treated in the RESET-Myositis phase I/II trial

Article

Author: Miller, Claire ; Williams, Jazmean ; Little, Courtney ; Stadanlick, Jason ; Hadi-Nezhad, Fatemeh ; Furmanak, Thomas ; Thompson, Daniel ; Lam, Quynh ; Cicarelli, Justin ; Werner, Mallorie ; Ellis, Alexandra ; Schmitt, Chris ; Nunez, Daniel ; Basu, Samik ; Mozaffar, Tahseen ; Volkov, Jenell ; Chang, David ; Vorndran, Zachary

Under compassionate use, chimeric antigen receptor (CAR) T cells have elicited durable remissions in patients with refractory idiopathic inflammatory myopathies (IIMs). Here, we report on the safety, efficacy, and correlative data of the first subject with the immune-mediated necrotizing myopathy (IMNM) subtype of IIM who received a fully human, 4-1BBz anti-CD19-CAR T cell therapy (CABA-201) in the RESET-Myositis phase I/II trial (NCT06154252). CABA-201 was well-tolerated following infusion. Notably, no evidence of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome was observed. Creatine kinase levels decreased, and muscular strength improved post-infusion. Peripheral B cells were depleted rapidly following infusion, and the subject achieved peripheral B cell aplasia by day 15 post-infusion. Peripheral B cells returned at 2 months post-infusion and were almost entirely transitional. Autoantibodies to SRP-9, SRP-72, SRP-54, and Ro-52, decreased relative to baseline, whereas antibodies associated with pathogens and vaccinations remained stable. The infusion product consisted of predominantly CD4⁺ effector memory T cells and exhibited in vitro cytolytic activity. Post-infusion, CABA-201 expansion peaked at day 15 and was preceded by a serum IFN-γ peak on day 8 with peaks in serum IL-12p40 and IP-10 on day 15. These data detail the safety, efficacy, and pharmacodynamics of CABA-201 in the first IMNM subject.

112

News (Medical) associated with Resecabtagene Autoleucel

05 Oct 2026

·www.biospace.com

Cabaletta Bio Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - October 5, 2026

PHILADELPHIA, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced the grant of inducement equity awards to four newly hired non-executive employees as a material inducement to commencing their employment with the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement awards are as follows: (i) non-qualified stock options to purchase an aggregate of 200,000 shares of the Company’s common stock with an exercise price of $2.46 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on September 21, 2026, (ii) non-qualified stock options to purchase an aggregate of 100,000 shares of the Company’s common stock with an exercise price of $2.00 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on September 28, 2026, and (iii) non-qualified stock options to purchase an aggregate of 85,000 shares of the Company’s common stock with an exercise price of $2.00 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on October 2, 2026. Each option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grant, and the remainder vesting in 12 equal quarterly installments for the three years thereafter. The stock options are subject to the terms and conditions of the Company’s 2025 Inducement Plan and the terms and conditions of the stock option agreements covering the grants. About Cabaletta Bio Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. Cabaletta’s lead product candidate, rese-cel, is an investigational 4-1BB-containing fully human CD19-CAR T cell therapy being advanced across the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology, and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit and connect with us on LinkedIn. Contacts Investors: investors@cabalettabio.com Media: media@cabalettabio.com

Cell TherapyImmunotherapy

05 Oct 2026

·www.cabalettabio.com

Cabaletta Bio Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

PHILADELPHIA, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced the grant of inducement equity awards to four newly hired non-executive employees as a material inducement to commencing their employment with the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement awards are as follows: (i) non-qualified stock options to purchase an aggregate of 200,000 shares of the Company’s common stock with an exercise price of $2.46 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on September 21, 2026, (ii) non-qualified stock options to purchase an aggregate of 100,000 shares of the Company’s common stock with an exercise price of $2.00 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on September 28, 2026, and (iii) non-qualified stock options to purchase an aggregate of 85,000 shares of the Company’s common stock with an exercise price of $2.00 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on October 2, 2026. Each option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grant, and the remainder vesting in 12 equal quarterly installments for the three years thereafter. The stock options are subject to the terms and conditions of the Company’s 2025 Inducement Plan and the terms and conditions of the stock option agreements covering the grants. About Cabaletta Bio Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. Cabaletta’s lead product candidate, rese-cel, is an investigational 4-1BB-containing fully human CD19-CAR T cell therapy being advanced across the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology, and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and connect with us on LinkedIn. Contacts Investors: investors@cabalettabio.com Media: media@cabalettabio.com Released October 5, 2026

Cell TherapyImmunotherapyClinical Study

01 Sep 2026

·www.globenewswire.com

Cabaletta Bio to Participate in Upcoming Investor Conferences

PHILADELPHIA, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced its participation in the following upcoming investor conferences: Wells Fargo 21st Annual Healthcare Conference: Meetings with investors on Tuesday, September 8, 2026, in Boston, MA.2026 Cantor Global Healthcare Conference: Meetings with investors and a webcasted fireside chat at 8:35 a.m. ET on Wednesday, September 9, 2026, in New York, NY.Morgan Stanley 24th Annual Global Healthcare Conference: Meetings with investors and a webcasted fireside chat at 10:45 a.m. ET on Monday, September 14, 2026, in New York, NY.H.C. Wainwright 28th Annual Global Investment Conference: Meetings with investors and a fireside chat at 8:30 a.m. ET on Wednesday, September 16, 2026, in New York, NY. The webcasted fireside chats will be available on the News and Events section of the Company’s website at www.cabalettabio.com. Archived replays will be available for 30 days. About Cabaletta BioCabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. Cabaletta’s lead product candidate, rese-cel, is an investigational 4-1BB-containing fully human CD19-CAR T cell therapy being advanced across the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology, and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and connect with us on LinkedIn. ContactsInvestors: investors@cabalettabio.comMedia: media@cabalettabio.com

100 Deals associated with Resecabtagene Autoleucel

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Scleroderma, Systemic	Phase 3	United States	Cabaletta Bio, Inc.	02 Jul 2024
Antisynthetase Syndrome	Phase 3	United States	Cabaletta Bio, Inc.	20 Dec 2023
Antisynthetase Syndrome	Phase 3	Germany	Cabaletta Bio, Inc.	20 Dec 2023
Antisynthetase Syndrome	Phase 3	Italy	Cabaletta Bio, Inc.	20 Dec 2023
Antisynthetase Syndrome	Phase 3	United Kingdom	Cabaletta Bio, Inc.	20 Dec 2023
Dermatomyositis	Phase 3	United States	Cabaletta Bio, Inc.	20 Dec 2023
Dermatomyositis	Phase 3	Germany	Cabaletta Bio, Inc.	20 Dec 2023
Dermatomyositis	Phase 3	Italy	Cabaletta Bio, Inc.	20 Dec 2023
Dermatomyositis	Phase 3	United Kingdom	Cabaletta Bio, Inc.	20 Dec 2023
Idiopathic Inflammatory Myopathies	Phase 3	United States	Cabaletta Bio, Inc.	20 Dec 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06121297 (RESET-SLE, ACR2026)	Phase 1/2	Lupus Nephritis	6	Rese-cel (resecabtagene autoleucel)	qetukcvjhr(qfqubxpdbb) = argrwfaohn lxwbaqqyul (mosmddqhki ) View more	Positive	06 Nov 2026
NCT06154252 (RESET-Myositis, ACR2026)	Phase 1/2	Dermatomyositis	6	Resecabtagene autoleucel (rese-cel)	fnnkhcmgom(fnlokxwxrb) = dgjuzdzauv qwfagvpxgs (udvljnnriw ) View more	Positive	06 Nov 2026
NCT06121297 (RESET-SLE, EULAR2026)	Phase 1/2	Idiopathic Inflammatory Myopathies \| Scleroderma, Systemic \| Systemic Lupus Erythematosus	27	rese-cel	dqeipsgwbb(supozqkghp) = kmhofqpogy uzdkxboaiz (zaishcieye, 41 - 81) View more	Positive	11 Jun 2026
NCT06328777 (RESET-SSc, EULAR2026)	Phase 1/2	Scleroderma, Systemic	6	RESECABTAGENE AUTOLEUCEL (Systemic sclerosis)	iawgakrfwm(cqsfoilmhv) = Two patients experienced Grade 1 CRS wancozkwba (jowrlqmxty ) View more	Positive	11 Jun 2026
NCT06154252 (RESET-Myositis, EULAR2026)	Phase 1/2	Idiopathic Inflammatory Myopathies	13	RESECABTAGENE AUTOLEUCEL	czsdusvodv(sjaupbgsvi) = yhyushulck ioarrxptfc (thwhxrljya ) View more	Positive	11 Jun 2026
NCT06121297 (RESET-SLETM, ACR2025)	Phase 1/2	Lupus Nephritis \| Systemic Lupus Erythematosus	7	Rese-cel	jrotswlejd(ilvifiztqq) = wxcdowscho oswsbtllat (keelpipssf ) View more	Positive	24 Oct 2025
NCT06154252 (RESET-Myositis, ACR2025)	Phase 1/2	Idiopathic Inflammatory Myopathies	6	Rese-cel	daglggtjpy(aqeleqexic) = Grade 1 cytokine release syndrome (CRS) in 3 of 6 patients, and no Grade 2 or higher CRS, dose-limiting toxicity or immune effector cell-associated neurotoxicity syndrome (ICANS). wsatussgwz (swbtgeskcy )	Positive	24 Oct 2025
NCT06154252 \| NCT06328777 \| NCT06121297 (RESET-SSc, Company_Website) Manual	Phase 1/2	Myositis \| Scleroderma, Systemic \| Systemic Lupus Erythematosus	10	resecabtagene autoleucel (RESET-Myositis)	-	Positive	18 Feb 2025
	Phase 1/2		10	resecabtagene autoleucel (RESET-SLE)	oixdaomuoz(obmusdncff) = tttqrponyn bpxewvgiep (gamrlocxfh ) View more	Positive	18 Feb 2025
RESET-Myositis (GlobeNewswire) Manual	Phase 1/2	Idiopathic Inflammatory Myopathies \| Scleroderma, Systemic \| Lupus Nephritis ... View more	8	CABA-201	iqxhjftuga(ahzeqkutqd) = xnffcgnklh vylwhxbeuc (tehyaznsty ) View more	Positive	18 Nov 2024
NCT06121297 (RESET-SLE, Biospace) Manual	Phase 1/2	Autoimmune Diseases \| Systemic Lupus Erythematosus \| Immune-mediated necrotising myopathy	2	CABA-201	aajrvgfyhv(xwbfoxjmig) = None vugvbeoqbk (qolmcekcsd ) View more	Positive	14 Jun 2024