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DRUG:

ssCART-19

i
Other names: ssCART-19, humanized CD19 CAR-T cells, ssCART-19 Cells
Associations
Company:
Shanghai Unicar
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
4ms
Clinical Study of U01(ssCART-19) in Patients With B-Cell Lymphoma (clinicaltrials.gov)
P1, N=30, Recruiting, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
New P1 trial
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cyclophosphamide • fludarabine IV • ssCART-19
6ms
CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=34, Recruiting, The First Affiliated Hospital of Soochow University | Trial completion date: Dec 2025 --> Jan 2040 | Trial primary completion date: Jun 2025 --> Jan 2025
Trial completion date • Trial primary completion date
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ssCART-19
7ms
CD19 CAR-T in relapsed t(8;21) AML: a single-center prospective phase II clinical trial. (PubMed, J Hematol Oncol)
After lymphodepletion with fludarabine and cyclophosphamide (FC), 5-20 × 106 cells per kilogram of CAR-T cells were administered. The 12-month cumulative incidence of relapse was 53.3%. These findings indicated that CD19 CAR-T was a safe and effective option for relapsed CD19-positive t(8;21) AML.
P2 data • Journal • IO biomarker
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TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • CD19 (CD19 Molecule) • RUNX1 (RUNX Family Transcription Factor 1) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1)
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FLT3-ITD mutation • CD19 positive • RUNX1-RUNX1T1 fusion
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cyclophosphamide • fludarabine IV • ssCART-19
1year
Safe and potent anti-CD19 CAR T-cells with shRNA-IL-6 gene silencing element in patients with refractory or relapsed B-cell acute lymphoblastic leukemia. (PubMed, Hemasphere)
Median progression-free survival was 24.17 months for ssCART-19 and 9.33 months for cCART-19 (p = 0.23). These data support the safety and efficacy of ssCART-19 for r/r B-ALL, suggesting its potential as a promising therapy.
Journal • CAR T-Cell Therapy
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IL6 (Interleukin 6)
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ssCART-19
1year
CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=27, Recruiting, The First Affiliated Hospital of Soochow University | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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ssCART-19
over1year
New P2 trial
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CD19 positive
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cyclophosphamide • fludarabine IV • ssCART-19
almost2years
CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=27, Recruiting, The First Affiliated Hospital of Soochow University | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
Trial completion date • Trial primary completion date
|
ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
ssCART-19
2years
The Clinical Outcome of Patients with Refractory/Relapsed Lymphoid Blastic Phase of Chronic Myeloid Leukemia Treated with CAR T-Cells Therapy (ASH 2023)
All patients received lymphodepletion with fludarabine (30 mg/m2 /d) and cyclophosphamide (300 mg/m2 /d) -based conditioning regimens on day −5 to −3...Among them, 8 patients with CML-LBC and 92 ph+ ALL patients received single CD19 CAR T therapy, others received tandem CD19/CD22 CAR T. The baseline characteristics of all patients were shown in Table 1... Worser sustained antitumor efficacy and long-term survival with CAR T-cells therapy in patients with CML-LBC compared to ph+ ALL patients, and ABL kinase region mutation is an independent risk factor for CR and LFS.
Clinical • Clinical data • CAR T-Cell Therapy • IO biomarker
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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cyclophosphamide • fludarabine IV • CD22-CART • ssCART-19
2years
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia (clinicaltrials.gov)
P1, N=10, Recruiting, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd | Trial completion date: Feb 2024 --> Dec 2025 | Trial primary completion date: Aug 2023 --> Dec 2024
Trial completion date • Trial primary completion date
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CD19 positive
|
ssCART-19
2years
Humanized CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=40, Recruiting, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2023 --> Dec 2024
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
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ssCART-19