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    DRUG CLASS:

    CD19-targeted CAR-T immunotherapy

    Related drugs:
    1d
    TRANSCEND-CLL-004: Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov)
    P1/2, N=209, Recruiting, Juno Therapeutics, a Subsidiary of Celgene | Active, not recruiting --> Recruiting | Trial completion date: Jul 2026 --> Nov 2027 | Trial primary completion date: Jul 2026 --> Nov 2027
    Enrollment open • Trial completion date • Trial primary completion date
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    PLCG2 (Phospholipase C Gamma 2) • CD5 (CD5 Molecule)
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    CD19 positive • PLCG2 mutation
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    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Breyanzi (lisocabtagene maraleucel)
    1d
    CAR-T Cell Therapy for Desensitization in Kidney Transplantation (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Initiation date: Mar 2024 --> May 2024
    Trial initiation date • CAR T-Cell Therapy
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    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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    cyclophosphamide • fludarabine IV • huCART19
    2d
    Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research (clinicaltrials.gov)
    P1, N=36, Recruiting, The Children's Hospital of Zhejiang University School of Medicine
    New P1 trial • CAR T-Cell Therapy
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    cyclophosphamide • Meta10-19
    4d
    CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=24, Recruiting, Marcela V. Maus, M.D.,Ph.D. | Trial completion date: Oct 2027 --> Jan 2028 | Trial primary completion date: Oct 2025 --> Jan 2027
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
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    CD79B (CD79b Molecule)
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    cyclophosphamide • fludarabine IV
    5d
    Persistent Cytopenia After CD19 CAR T Therapy in Relapsed/Refractory DLBCL Patients Could Be a Predictor of Efficacy and Side Effects. (PubMed, Cell Transplant)
    Patients received lymphodepleting chemotherapy with fludarabine and cyclophosphamide before CAR T cell therapy. Progression-free and overall survival were higher in patients with Grades 3-4 persistent cytopenia than in those without cytopenia. Therefore, persistent cytopenia after anti-CD19 CAR T cell therapy in patients with R/R DLBCL can predict therapeutic efficacy and AEs, allowing clinicians to determine the efficiency of CD-19 CAR T cell therapy and the associated AEs.
    Journal • Adverse events
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    IL6 (Interleukin 6)
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    cyclophosphamide • fludarabine IV
    7d
    Efficacy and safety of bendamustine for lymphodepletion before lisocabtagene maraleucel. (PubMed, J Hematol Oncol)
    Bendamustine has been retrospectively shown to be an effective and safe lymphodepletion regimen prior to the anti-CD19 chimeric antigen receptor T cell (CART) products tisagenlecleucel and axicabtagene ciloleucel, as well as the anti-BCMA CART products idecabtagene vicleucel and ciltacabtagene autoleucel. Neutropenia ≥ grade 3 was observed in 29.0% of patients; thrombocytopenia ≥ grade 3 occurred in 9.7%. In conclusion, bendamustine lymphodepletion before liso-cel appears to be a strategy that can drive tumor responses while ensuring a mild toxicity profile.
    Journal
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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) • bendamustine • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel)
    8d
    RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov)
    P1/2, N=12, Not yet recruiting, Cabaletta Bio | Trial completion date: Jul 2028 --> Sep 2029 | Initiation date: May 2024 --> Aug 2024 | Trial primary completion date: Jul 2028 --> Sep 2029
    Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
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    cyclophosphamide
    8d
    A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Kyverna Therapeutics
    New P2 trial • CAR T-Cell Therapy
    10d
    MPCT-012L: Study of IMPT-314 in R/R Aggressive B-cell NHL (clinicaltrials.gov)
    P1/2, N=150, Recruiting, ImmPACT Bio | N=100 --> 150
    Enrollment change
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    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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    BCL6 rearrangement • BCL2 rearrangement
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    IMPT-314
    11d
    A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Takeda
    New P1 trial
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    cyclophosphamide • TAK-007
    11d
    A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov)
    P1/2, N=20, Completed, Celgene | Recruiting --> Completed | N=121 --> 20 | Trial completion date: Dec 2024 --> Jan 2024 | Trial primary completion date: Dec 2024 --> Jan 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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    CD19 (CD19 Molecule)
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    CD19 expression
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    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    11d
    Context matters: Tumor microenvironments impact cellular therapy success. (PubMed, Cell Rep Med)
    present data from pretreatment tumor biopsies taken on the ZUMA-7 trial. Their results identify tumor microenvironment (TME) contexts and level of CD19 expression as prognostic indicators for responses to axicabtagene ciloleucel (axi-cel).
    Journal
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    CD19 (CD19 Molecule)
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    CD19 expression
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    Yescarta (axicabtagene ciloleucel)
    14d
    Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients. (clinicaltrials.gov)
    P1, N=12, Recruiting, Shanghai Tongji Hospital, Tongji University School of Medicine
    New P1 trial • CAR T-Cell Therapy
    15d
    Early CAR- CD4+ T-lymphocytes recovery following CAR-T cell infusion: A worse outcome in diffuse large B cell lymphoma. (PubMed, EJHaem)
    Among possible determinants of CD4+ T cell recovery, we recognized infusion of a 4-1BB product (tisagenlecleucel, TSA) in comparison with a CD28 (axicabtagene/brexucabtagene, AXI/BRX) (hazard ratio [HR] [95% CI]: 5.79 [1.16-24.12] p = 0.016). We conclude that a faster CAR- CD4+ T cell recovery is associated with TSA as compared to AXI/BRX. Month-1 CAR- CD4+ T cell subset recovery could represent a "red flag" for CAR-T cell therapy failure in DLBCL patients.
    Journal • CAR T-Cell Therapy
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    CD4 (CD4 Molecule)
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    Yescarta (axicabtagene ciloleucel) • Kymriah (tisagenlecleucel-T) • Tecartus (brexucabtagene autoleucel)
    15d
    Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients (clinicaltrials.gov)
    P=N/A, N=353, Recruiting, Beijing GoBroad Hospital | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
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    CD22 (CD22 Molecule)
    15d
    A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=12, Recruiting, EdiGene Inc.
    New P1 trial
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    IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha)
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    cyclophosphamide • fludarabine IV • ATHENA CAR-T
    15d
    A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Kyverna Therapeutics | Phase classification: P1 --> P1/2 | N=12 --> 32
    Phase classification • Enrollment change • CAR T-Cell Therapy
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    cyclophosphamide • fludarabine IV
    17d
    Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration) (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
    New P2 trial
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    CD19 positive
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    cyclophosphamide • fludarabine IV • humanized CD19 CAR-T cells
    17d
    Tisagenlecleucel In Primary CNS Lymphoma (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Matthew J. Frigault, M.D. | Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Dec 2024
    Enrollment closed • Trial completion date
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    Kymriah (tisagenlecleucel-T)
    18d
    Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov)
    P=N/A, N=10, Recruiting, PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    18d
    Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1/2, N=66, Not yet recruiting, National Cancer Institute (NCI)
    New P1/2 trial • CAR T-Cell Therapy
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    CD19 expression
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    Rituxan (rituximab) • cyclophosphamide • fludarabine IV
    21d
    Post-infusion PD-1+CD8+CAR-T cells identify patients responsive to CD19-CAR-T therapy in non-Hodgkin's lymphoma. (PubMed, Blood Adv)
    Additionally, we identified a subset of PD-1+ CD8+ CAR+ T cells with effector-like function that was increased in patients who achieved a CR and was associated with Grade 3 or higher immune effector cell-associated neurotoxicity syndrome. Here we identified robust biomarkers of response to CD28-CAR-T and highlight the importance of PD-1 positivity in CD8+ CAR-T cells post-infusion in achieving CR.
    Journal • CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
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    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    21d
    Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov)
    P=N/A, N=10, Not yet recruiting, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
    New trial
    21d
    A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis (clinicaltrials.gov)
    P1, N=12, Recruiting, Stanford University | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
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    bendamustine
    21d
    ZUMA-25: Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (clinicaltrials.gov)
    P2, N=90, Recruiting, Kite, A Gilead Company | Trial completion date: Dec 2027 --> Mar 2025 | Trial primary completion date: Dec 2027 --> Mar 2025
    Trial completion date • Trial primary completion date • Pan tumor
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    cyclophosphamide • fludarabine IV • Tecartus (brexucabtagene autoleucel)
    22d
    RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov)
    P1/2, N=12, Not yet recruiting, Cabaletta Bio
    New P1/2 trial • CAR T-Cell Therapy
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    cyclophosphamide
    23d
    huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1, N=55, Terminated, Fred Hutchinson Cancer Center | Active, not recruiting --> Terminated; Terminated due to slow enrollment and end of funding
    Trial termination • CAR T-Cell Therapy
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    BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6) • IL6 (Interleukin 6) • CD4 (CD4 Molecule) • SELL (Selectin L)
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    CD19 positive • CD8 expression • CD19 expression • BCL6 rearrangement • BCL2 rearrangement • CD20 negative • CD4 expression
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    cyclophosphamide • fludarabine IV • JCAR014
    23d
    Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, Bristol-Myers Squibb
    New trial
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    Breyanzi (lisocabtagene maraleucel) • Abecma (idecabtagene vicleucel)
    24d
    CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases (clinicaltrials.gov)
    P1, N=45, Recruiting, Zhejiang University | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    25d
    ZUMA-24: Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Kite, A Gilead Company | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
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    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV
    28d
    ZUMA-22: Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov)
    P3, N=230, Recruiting, Kite, A Gilead Company | Trial completion date: Jan 2031 --> Oct 2030 | Trial primary completion date: Jan 2031 --> Oct 2030
    Trial completion date • Trial primary completion date
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • Yescarta (axicabtagene ciloleucel) • prednisone • bendamustine • fludarabine IV
    28d
    CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, David Porter | Trial completion date: Feb 2028 --> Jun 2028 | Initiation date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2028 --> Jun 2028
    Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
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    cyclophosphamide • fludarabine IV
    28d
    Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=396, Recruiting, SWOG Cancer Research Network | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date • CAR T-Cell Therapy
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    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
    28d
    P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies (clinicaltrials.gov)
    P1, N=100, Recruiting, Poseida Therapeutics, Inc. | Initiation date: Jan 2024 --> Apr 2024
    Trial initiation date • CAR T-Cell Therapy
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    CD20 (Membrane Spanning 4-Domains A1) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
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    CD20 positive
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    P-CD19CD20-ALLO1 • rimiducid (AP1903)
    28d
    A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies (clinicaltrials.gov)
    P3, N=0, Withdrawn, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | N=200 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
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    Rituxan (rituximab) • cyclophosphamide • Zydelig (idelalisib) • Breyanzi (lisocabtagene maraleucel) • bendamustine • fludarabine IV • Belrapzo (bendamustine RTD)
    28d
    Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients (clinicaltrials.gov)
    P=N/A, N=353, Not yet recruiting, Beijing GoBroad Hospital
    New trial • CAR T-Cell Therapy
    |
    CD22 (CD22 Molecule)
    29d
    Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas (clinicaltrials.gov)
    P2, N=27, Recruiting, Patrick C. Johnson, MD | Not yet recruiting --> Recruiting | Trial completion date: Sep 2029 --> Mar 2029 | Trial primary completion date: Sep 2024 --> Mar 2025
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    cyclophosphamide • Calquence (acalabrutinib) • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    29d
    CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Zhejiang University
    New P1 trial
    29d
    Administration of Anti-CD19-chimeric-antigen-receptor-transduced T Cells From the Original Transplant Donor to Patients With Recurrent or Persistent B-cell Malignancies After Allogeneic Stem Cell Transplantation (clinicaltrials.gov)
    P1, N=85, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Apr 2024
    Trial completion • Trial completion date
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    1m
    A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3) (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Kyverna Therapeutics
    New P1/2 trial
    |
    cyclophosphamide • fludarabine IV
    1m
    Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Roswell Park Cancer Institute
    New P1 trial • CAR T-Cell Therapy
    |
    cyclophosphamide • fludarabine IV
    1m
    B-cell-directed CAR-T cell therapy activates CD8+ cytotoxic CARneg bystander T-cells in non-human primates and patients. (PubMed, Blood)
    A transcriptionally similar population was identified in patients following Tisagenlecleucel infusion...In vitro activated and patient-derived T-cells with the bystander phenotype efficiently killed leukemic cells through a TCR-independent mechanism. Collectively, this dataset provides the first comprehensive identification and profiling of CARneg bystander CD8+ T-cells following B-cell targeting CAR-T cell therapy and suggests a novel mechanism through which CAR-T cell infusion might trigger enhanced anti-leukemic responses.
    Journal • CAR T-Cell Therapy • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • IL2 (Interleukin 2) • KIR3DL2 (Killer Cell Immunoglobulin Like Receptor Three Ig Domains And Long Cytoplasmic Tail 2) • IL15 (Interleukin 15) • KLRD1 (Killer Cell Lectin Like Receptor D1)
    |
    Kymriah (tisagenlecleucel-T)