- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Cytogenetic Abnormalities Following CAR T Cell Therapy for B-Cell Malignancies (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3827;
P1, P1/2
We identified 21 patients (22%) with new cytogenetic abnormalities after LV20.19 CAR T cell therapy. Among this subset, the median age was 64 years (46-75) and 86% (n=18) were male sex.
- |||||||||| CAR20.19.22 T / Miltenyi Biotec, Medical College of Wisconsin
Phase 1 Study of Trispecific Anti-CD20, Anti-CD19, Anti-CD22 (CAR20.19.22) T Cells for Relapsed, Refractory B-Cell Malignancies (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3816;
P1
While preclinical xenograft studies for this vector demonstrated potent in-vivo efficacy, these data demonstrate the importance of human investigation and how manipulations in CAR design can impact construct efficacy. To our knowledge this is the first ICOS CAR administered to humans, and these early findings suggest careful consideration is needed for future CARs dependent on ICOS signaling rather than traditional 41BB or CD28 co-stimulation.
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Single-cell multimodal functional analysis of bispecific CD20/CD19 chimeric antigen receptor T-cells provides better clinical correlates compared to traditional bulk potency assays (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_825;
P1/2
To compare whether the traditional or multimodal assays provide a more accurate depiction of how these cells behave after administration to patients with NHL, we compared the functional readouts from the assays and determined which parameters were associated with clinical response using LV20.19 CAR-Ts from 6 subjects enrolled in an ongoing clinical trial (NCT04186520) at the Medical College of Wisconsin...All operations were under principles of Good Clinical Practice with established Standard Operating Procedures and protocols for sample receipt, processing, freezing, and analysis. Samples are de-identified for compliance with HIPAA rules.
- |||||||||| CAR20.19.22 T / Miltenyi Biotec, Medical College of Wisconsin
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (clinicaltrials.gov) - Sep 19, 2024
P1, N=4, Terminated,
All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Trial completion date, Trial primary completion date, CAR T-Cell Therapy: PRO00037171: CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (clinicaltrials.gov) - Jun 10, 2024
P1/2, N=100, Recruiting,
These data support our planned phase 1 clinical trial to assess the safety of pirtobrutinib as bridging and maintenance therapy with LV20.19 CAR T-cell therapy (NCT05990465). Trial completion date: Dec 2025 --> Jan 2025 | Trial primary completion date: Dec 2025 --> Jan 2025
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, CAR T-Cell Therapy: LV20.19 CAR T-Cells in Combination with Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (clinicaltrials.gov) - May 19, 2024
P1, N=12, Not yet recruiting,
Trial completion date: Dec 2025 --> Jan 2025 | Trial primary completion date: Dec 2025 --> Jan 2025 Trial completion date: Feb 2025 --> Jul 2027 | Initiation date: Apr 2024 --> Jul 2024 | Trial primary completion date: Nov 2024 --> Jul 2026
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Fresh Versus Cryopreserved LV20.19 CAR T-Cell Therapy for Relapsed, Refractory DLBCL and Follicular Lymphoma () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_945;
P1/2
Cryopreservation of LV20.19 CAR T-cell therapy had no meaningful impact on ORR, DOR, toxicity profile, time to CRS, or in-vivo expansion. Although fresh products facilitate shorter time from apheresis to infusion, cryopreservation may allow for rapid advancement of products to multicenter trials and licensure.
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Phase 1 Trial of LV20.19 CAR T-Cells for Relapsed, Refractory CLL and Richter's Transformation (Stars at Night B4 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) - Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_678;
P1/2
With two DLTs in the CLL cohort, the dose for future CLL pts was reduced to 1x10e6 cells/kg. Additional studies are needed to understand how CLL biology drives CAR IEC-HS.
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Adaptive Manufacturing of LV20.19 CAR T-Cells for Relapsed, Refractory Mantle Cell Lymphoma (SDCC - Room 6A) - Nov 3, 2023 - Abstract #ASH2023ASH_5208;
P1/2
Adaptive MF enriched the final product with higher percentages of T-SCM/T-CM CAR cells and allowed most pts to receive CAR-T cells within 8 days of apheresis. Dual targeting of CD20 and CD19 with CAR-T cells may improve outcomes in pts with relapsed, refractory MCL.
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Trial completion date, Trial primary completion date: CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL (clinicaltrials.gov) - Jul 7, 2023
P1, N=24, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Feb 2024 --> Jun 2026 | Trial primary completion date: Oct 2023 --> Jun 2025
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Enrollment change, Trial primary completion date, CAR T-Cell Therapy: PRO00037171: CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (clinicaltrials.gov) - Jun 8, 2023
P1/2, N=100, Recruiting,
Trial completion date: Feb 2024 --> Jun 2026 | Trial primary completion date: Oct 2023 --> Jun 2025 N=65 --> 100 | Trial primary completion date: Dec 2023 --> Dec 2025
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Bispecific Anti-CD20/Anti-CD19 (LV20.19) CAR T-Cells for Richter’s Transformation () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_1166;
P1, P1/2
To date, there is limited data on outcomes for RT with CAR T-cell therapy. Given historical outcomes, bispecific LV20.19 CAR T cells offer a promising strategy for R/R RT.
- |||||||||| Clinical Characteristics and Patient Outcomes with HLH-like Toxicities after CD19 Based CAR T-Cell Therapy () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_786;
METHODS We performed a retrospective review of pts with relapsed/refractory B-cell malignancies treated with autologous CD19 or bispecific lentiviral anti-CD20/CD19 (LV20.19) CAR T-cell therapy at the Medical College of Wisconsin Cancer Center from 01/2018-8/2022...All pts had CRS and all required tocilizumab, while only 9 pts had neurotoxicity, and all received steroids for management...One patient received etoposide and ruxolitinib as third and fourth line therapy, respectively...While manageable with steroids and/or anakinra, most pts ultimately died from infection or relapse. New strategies for earlier diagnosis and improved management are indicated.
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Single Cell Cytokine Analyses of Bispecific, Tandem, Anti-CD20, Anti-CD19 CAR T-Cells from Patients with Relapsed, Refractory B-Cell Malignancies () - Nov 29, 2022 - Abstract #ASH2022ASH_7773;
P1, P1/2
For cells expanded in IL-7+15 vs IL-2, the global PFA was 53.14% vs 40.12%, p=0.01, CD8 PFA was 51.15% vs 41.24% p=0.01, while the CD4 PFA was 55.05% vs 46.23%, p=0.08, (Figure 1A). Similarly, the global PSI was 1508 vs 956 p=0.0003, CD8 PSI was 1333 vs 865 p=0.0009, and CD4 PSI was 1580 vs 865, p<0.0001.
- |||||||||| CD30 biAb-AATC / Medical College of Wisconsin, Tundra Targeted Therap
New P1/2 trial: CD30biAb-AATC for CD30+ Malignancies (clinicaltrials.gov) - Sep 19, 2022
P1/2, N=42, Not yet recruiting,
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Trial completion, Trial completion date: Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell (clinicaltrials.gov) - Jul 14, 2022
P1, N=26, Completed,
Stimulation with either CD19 or CD20 antigens resulted in similar levels of analyte activation, suggesting that this product may have efficacy in CD19- patient populations. Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Aug 2021
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Enrollment change, Trial completion date, Trial primary completion date, CAR T-Cell Therapy: PRO00037171: CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (clinicaltrials.gov) - Jul 7, 2022
P1/2, N=65, Recruiting,
Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Aug 2021 N=32 --> 65 | Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: May 2023 --> Dec 2023
- |||||||||| CAR20.19.22 T / Miltenyi Biotec, Medical College of Wisconsin
Enrollment open: CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (clinicaltrials.gov) - Jul 6, 2022
P1, N=36, Recruiting,
N=32 --> 65 | Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: May 2023 --> Dec 2023 Not yet recruiting --> Recruiting
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Trial completion date, Trial primary completion date: CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL (clinicaltrials.gov) - Apr 12, 2022
P1, N=24, Recruiting,
Findings from this exploratory study are preliminary and warrant validation in a larger cohort. Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Oct 2022 --> Oct 2023
- |||||||||| CAR20.19.22 T / Miltenyi Biotec, Medical College of Wisconsin
Enrollment change: CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (clinicaltrials.gov) - Apr 8, 2022
P1, N=36, Not yet recruiting,
Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Oct 2022 --> Oct 2023 N=24 --> 36
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Phase 1/2 Trial of Bispecific LV20.19 CAR T-Cells for Relapsed, Refractory B-Cell Non-Hodgkin Lymphoma (Salt Palace Convention Center Ballroom D) - Dec 3, 2021 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_729;
P1/2
Bispecific LV20.19 CAR T-cells expanded with IL7+15 are safe and efficacious for R/R B-cell NHL with a high ORR and low rates of grade ≥3 CRS or ICANS. Early results demonstrate immunophenotypic differences and improved responses among pts treated with a shorter 8-day MF process.
- |||||||||| CAR-20/19-T Cells / Medical College of Wisconsin, Miltenyi Biotec
Associations between Socioeconomic Status and Bispecific LV20.19 CAR T-Cell Therapy Outcomes (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5794;
P1
Earlier CRS onset and increased pain were also seen in low SES patients, with qualitatively higher incidences of CRS, neurotoxicity, and poor sleep. Future work will focus on acquiring a larger sample to further delineate the impact of SES on cancer outcome disparities among CAR T-cell recipients, including but not limited to PROs, neurotoxicity, and survival.
- |||||||||| Trial completion date, Trial primary completion date, CAR T-Cell Therapy: Long-term Follow-up Study of Patients Receiving CAR-T Cells (clinicaltrials.gov) - Sep 24, 2021
P=N/A, N=24, Recruiting,
Not available. Trial completion date: Aug 2041 --> Jan 2035 | Trial primary completion date: Aug 2021 --> Jan 2035
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] BASELINE TUMOR BURDEN CORRELATES WITH RESPONSE BUT NOT TOXICITIES IN PATIENTS TREATED WITH BISPECIFIC ANTI-CD20, ANTI-CD19 CAR-T CELLS () - May 13, 2021 - Abstract #EHA2021EHA_1106;
P1
Background Bispecific anti-CD20, anti-CD19 (LV20.19) CAR T-cells may improve outcomes in relapsed, refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) by limiting relapse due to single antigen downregulation...In our LV20.19 experience, overall CRS and neurotoxicity rates were low and the low overall incidence may limit statistical power to detect an association with tumor burden. With accumulating evidence that higher pre–CAR-T tumor burden is associated with inferior response rates, developing novel approaches to debulk patients safely prior to CAR-T is indicated.
- |||||||||| anti-SARS-CoV-2 convalescent plasma / Medical College of Wisconsin
Enrollment closed: Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients (clinicaltrials.gov) - Jan 7, 2021
P2, N=131, Active, not recruiting,
With accumulating evidence that higher pre–CAR-T tumor burden is associated with inferior response rates, developing novel approaches to debulk patients safely prior to CAR-T is indicated. Recruiting --> Active, not recruiting
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