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SC291
i
Other names: SC291, hypoimmune-modified CD19-directed allogeneic CAR T therapy, HIP CD19 CAR T, SC 291, SC-291
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News alerts, weekly reports and conference planners
Company:
Sana Biotech
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
10d
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM) (clinicaltrials.gov)
P1, N=7, Active, not recruiting, Sana Biotechnology | N=36 --> 7 | Recruiting --> Active, not recruiting
Enrollment closed • Enrollment change
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cyclophosphamide • fludarabine IV • SC291
4ms
Hypoimmune CD19 CAR T cells evade allorejection in patients with cancer and autoimmune disease. (PubMed, Cell Stem Cell)
The primary T cell product SC291 was engineered with a CD19 CAR, T cell receptor alpha constant (TRAC) knockout, and the hypoimmune (HIP) edits of HLA depletion and CD47 overexpression...The lack of antibodies against the HLA-replete CAR T cells was identified as a marker for deep tissue CD19 cell depletion, and all patients without such antibodies for 60 days showed concomitant B cell depletion in peripheral blood. The immune data presented support the reliability of the HIP concept to evade allorejection.
Journal • IO biomarker
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CD47 (CD47 Molecule)
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SC291
1year
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT) (clinicaltrials.gov)
P1, N=16, Active, not recruiting, Sana Biotechnology | Recruiting --> Active, not recruiting | N=57 --> 16 | Trial completion date: Dec 2027 --> Nov 2038 | Trial primary completion date: Dec 2026 --> Nov 2025
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • IO biomarker
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cyclophosphamide • fludarabine IV • SC291
over1year
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM) (clinicaltrials.gov)
P1, N=36, Recruiting, Sana Biotechnology | Not yet recruiting --> Recruiting
Enrollment open • CAR T-Cell Therapy
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cyclophosphamide • fludarabine IV • SC291
almost2years
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM) (clinicaltrials.gov)
P1, N=36, Not yet recruiting, Sana Biotechnology
New P1 trial • CAR T-Cell Therapy
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cyclophosphamide • fludarabine IV • SC291
2years
Identification of Healthy Donor Phenotypic and Functional Signatures That Predict Allogeneic, Hypoimmune CD19-Directed CAR T Cell Potency (ASH 2023)
"In vivo efficacy was evaluated using a systemic NALM-6 challenge in immune-deficient NSG mice at HIP CD19 CAR T cell doses of 5e5 and 5e6 cells per animal...Outperforming donors also showed reduced expression of MHC class II of alpha and beta heterodimers (HLA-DQA1 and HLA-DQB1). The information collected across phenotypic and functional comparisons will be compared with clinical performance."
CAR T-Cell Therapy • Clinical
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CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD47 (CD47 Molecule) • B2M (Beta-2-microglobulin) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1) • HLA-DQA1 (Major Histocompatibility Complex, Class II, DQ Alpha 1) • IL17A (Interleukin 17A) • IL22 (Interleukin 22) • IL5 (Interleukin 5) • TRB (T Cell Receptor Beta Locus)
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CD19 expression • CD47 overexpression • CD47 expression • MHC-II expression
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nCounter® CAR-T Characterization Panel
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SC291
2years
Phase 1 Study of SC291, a Hypoimmune, Allogeneic CD19-Directed CAR T Cell Therapy for Relapsed/Refractory B-Cell Malignancies (ARDENT) - Initial Clinical Data (ASH 2023)
The initial patient, a 74-year-old male with CLL (unmutated IGHV, del(11q), BTK C481S mutation) and 3 prior lines of therapy (FCR, ibrutinib, venetoclax + rituximab), received a LD regimen of cyclophosphamide 500 mg/m 2 and fludarabine 24 mg/m 2 (daily for 3 days) followed by a starting dose of 60 million CAR+ SC291 cells (of which approximately 80% are fully HIP engineered cells). Immune assays demonstrated that the CD19 HIP CAR T cell subpopulation effectively evades the host adaptive and innate immune responses and could overcome the allogeneic barrier in humans. Additional data from the ARDENT study will be presented at the time of the conference.
Clinical data • P1 data • CAR T-Cell Therapy
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CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • IGH (Immunoglobulin Heavy Locus) • IFNG (Interferon, gamma) • CD47 (CD47 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
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Chr del(11q) • CD19 expression • CD47 overexpression • CD47 expression • CD19 overexpression
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • cyclophosphamide • fludarabine IV • SC291
over2years
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT) (clinicaltrials.gov)
P1, N=54, Recruiting, Sana Biotechnology
New P1 trial • CAR T-Cell Therapy
|
cyclophosphamide • fludarabine IV • SC291
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