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DRUG CLASS:

CD19-targeted CAR-T immunotherapy

Related drugs:
13h
FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov)
P1, N=54, Active, not recruiting, Fate Therapeutics | Trial primary completion date: Sep 2024 --> Jun 2025
Trial primary completion date
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CD19 (CD19 Molecule)
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cyclophosphamide • fludarabine IV • FT819
14h
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus (clinicaltrials.gov)
P1/2, N=28, Recruiting, Cabaletta Bio | N=12 --> 28 | Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Dec 2027 --> Dec 2029
Enrollment change • Trial completion date • Trial primary completion date
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cyclophosphamide • fludarabine IV
21h
Autologous Bedside CD19 CAR T-cell Therapy for B-ALL (clinicaltrials.gov)
P1, N=50, Not yet recruiting, The General Hospital of Western Theater Command
New P1 trial
1d
Emerging role of lisocabtagene maraleucel chimeric antigen receptor-T cell in nodal and gastrointestinal follicular lymphoma. (PubMed, World J Gastroenterol)
Comparative insights highlight the advantages of liso-cel over other CAR-T cell products, such as axicabtagene ciloleucel and tisagenlecleucel in terms of toxicity, logistics, and outpatient feasibility. With ongoing improvements in manufacturing, accessibility, and biomarker development, liso-cel is well-positioned to become a central component in the evolving treatment paradigm for FL. However, challenges remain regarding durability of response, cost, and access, which warrant careful discussion.
Review • Journal • IO biomarker
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
1d
New P1 trial
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cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)
2d
Long-term Follow up Local Registry Study of Kymriah in South Korea (clinicaltrials.gov)
P=N/A, N=179, Recruiting, Novartis Pharmaceuticals | N=500 --> 179
Enrollment change
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Kymriah (tisagenlecleucel-T)
2d
Endothelial dysfunction and proinflammatory state determine severe hematotoxicity and inferior outcome of CAR-T therapy. (PubMed, Hemasphere)
To identify predictive biomarkers, we performed flow cytometry and multiplex assays before and early after CAR-T infusion on 78 patients (ide-cel n = 31; axi-cel n = 24; and cilta-cel n = 23) undergoing CAR-T therapy. Baseline sIL-2R and sVCAM-1 demonstrated robust predictive value for prolonged neutropenia, severe infections, and mortality independently of key clinical variables such as the underlying disease and CAR-T product. Integration of these markers improves existing models and can help to refine risk assessment and guide individualized patient management in CAR-T therapy.
Journal • IO biomarker
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IL2RA (Interleukin 2 receptor, alpha) • VCAM1 (Vascular Cell Adhesion Molecule 1)
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Yescarta (axicabtagene ciloleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel)
3d
PiNACLE-H2H: A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (clinicaltrials.gov)
P3, N=400, Recruiting, Lyell Immunopharma, Inc. | Not yet recruiting --> Recruiting
Enrollment open
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • rondecabtagene autoleucel (LYL314)
3d
New P2 trial
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zorpocabtagene autoleucel (MB-CART 19.1)
4d
New trial • Real-world evidence
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Yorwida (inaticabtagene autoleucel)
4d
ODIN: Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta (clinicaltrials.gov)
P1, N=40, Recruiting, University Health Network, Toronto | Trial completion date: Jun 2027 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Sep 2027
Trial completion date • Trial primary completion date
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CD20 negative
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cyclophosphamide • Yescarta (axicabtagene ciloleucel)
4d
NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
P1, N=24, Not yet recruiting, Washington University School of Medicine | Trial completion date: Apr 2028 --> Aug 2028 | Initiation date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jul 2027 --> Nov 2027
Trial completion date • Trial initiation date • Trial primary completion date
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)