This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.

Start Date01 Jan 2025

Sponsor / Collaborator

Medical College of Wisconsin

100 Clinical Results associated with LV20.19 CAR T cells(Medical College of Wisconsin)

100 Translational Medicine associated with LV20.19 CAR T cells(Medical College of Wisconsin)

100 Patents (Medical) associated with LV20.19 CAR T cells(Medical College of Wisconsin)

Literatures (Medical) associated with LV20.19 CAR T cells(Medical College of Wisconsin)

01 Aug 2022·CytotherapyQ3 · MEDICINE

Bispecific targeting of CD20 and CD19 increases polyfunctionality of chimeric antigen receptor T-cell products in B-cell malignancies

Q3 · MEDICINE

Article

Author: Shah, Nirav N ; Szabo, Aniko ; Schneider, Dina ; Zurko, Joanna C ; Chaney, Katherine ; Johnson, Bryon D ; Xu, Huiqing ; Hari, Parameswaran

BACKGROUND AIMSSelective immune pressure contributes to relapse due to target antigen downregulation in patients treated with anti-CD19 chimeric antigen receptor (CAR) T cells. Bispecific lentiviral anti-CD20/anti-CD19 (LV20.19) CAR T cells may prevent progression/relapse due to antigen escape. Highly polyfunctional T cells within a CAR T-cell product have been associated with response in single-antigen-targeted anti-CD19 CAR T cells.METHODSThe authors performed a single-cell proteomic analysis to assess polyfunctional cells in our LV20.19 CAR T-cell product. Analysis was limited to those treated at a fixed dose of 2.5 × 10⁶ cells/kg (n = 16). Unused pre-infusion CAR T cells were thawed, sorted into CD4/CD8 subsets and stimulated with K562 cells transduced to express CD19 or CD20. Single-cell production of 32 individual analytes was measured and polyfunctionality and polyfunctional strength index (PSI) were calculated.RESULTSFifteen patients had adequate leftover cells for analysis upon stimulation with CD19, and nine patients had adequate leftover cells for analysis upon stimulation with CD20. For LV20.19 CAR T cells, PSI was 866-1109 and polyfunctionality was 40-45%, which were higher than previously reported values for other CAR T-cell products.CONCLUSIONSStimulation with either CD19 or CD20 antigens resulted in similar levels of analyte activation, suggesting that this product may have efficacy in CD19- patient populations.

01 Oct 2020·Nature MedicineQ1 · MEDICINE

Bispecific anti-CD20, anti-CD19 CAR T cells for relapsed B cell malignancies: a phase 1 dose escalation and expansion trial

Q1 · MEDICINE

Article

Author: Keever-Taylor, Carolyn A ; Schneider, Dina ; Szabo, Aniko ; Krueger, Winfried ; Hari, Parameswaran ; Dropulić, Boro ; Cunningham, Ashley ; Kadan, Michael J ; Johnson, Bryon D ; Shah, Nirav N ; Yim, Sharon ; Orentas, Rimas ; Fenske, Timothy S ; Hamadani, Mehdi ; Zhu, Fenlu ; Worden, Andrew A

Chimeric antigen receptor (CAR) T cells targeting CD19 are a breakthrough treatment for relapsed, refractory B cell malignancies^1-5. Despite impressive outcomes, relapse with CD19^- disease remains a challenge. We address this limitation through a first-in-human trial of bispecific anti-CD20, anti-CD19 (LV20.19) CAR T cells for relapsed, refractory B cell malignancies. Adult patients with B cell non-Hodgkin lymphoma or chronic lymphocytic leukemia were treated on a phase 1 dose escalation and expansion trial (NCT03019055) to evaluate the safety of 4-1BB-CD3ζ LV20.19 CAR T cells and the feasibility of on-site manufacturing using the CliniMACS Prodigy system. CAR T cell doses ranged from 2.5 × 10⁵-2.5 × 10⁶ cells per kg. Cell manufacturing was set at 14 d with the goal of infusing non-cryopreserved LV20.19 CAR T cells. The target dose of LV20.19 CAR T cells was met in all CAR-naive patients, and 22 patients received LV20.19 CAR T cells on protocol. In the absence of dose-limiting toxicity, a dose of 2.5 × 10⁶ cells per kg was chosen for expansion. Grade 3-4 cytokine release syndrome occurred in one (5%) patient, and grade 3-4 neurotoxicity occurred in three (14%) patients. Eighteen (82%) patients achieved an overall response at day 28, 14 (64%) had a complete response, and 4 (18%) had a partial response. The overall response rate to the dose of 2.5 × 10⁶ cells per kg with non-cryopreserved infusion (n = 12) was 100% (complete response, 92%; partial response, 8%). Notably, loss of the CD19 antigen was not seen in patients who relapsed or experienced treatment failure. In conclusion, on-site manufacturing and infusion of non-cryopreserved LV20.19 CAR T cells were feasible and therapeutically safe, showing low toxicity and high efficacy. Bispecific CARs may improve clinical responses by mitigating target antigen downregulation as a mechanism of relapse.

Haematologica

Associations between socioeconomic status and bispecific LV20.19 CAR T-cell therapy outcomes

Letter

Author: Cole, Steve W ; Wu, Ruizhe ; Hillard, Cecilia J ; Sauber, Garrett ; Shah, Nirav N ; Hackett, Edward ; Cusatis, Rachel N ; Szabo, Aniko ; Johnson, Bryon ; Aughey, Elizabeth ; Knight, Jennifer M

Chimeric antigen receptor (CAR) T-cell therapy utilization has risen sharply in recent years, becoming a standard approach for refractory B-cell malignancies.The current study population (n=15) is derived from the previously reported parent study (n=22) evaluating patients with relapsed, refractory B-cell malignancies treated with LV20.19 CAR T cells on a phase I/Ib clin. trial ( clinicaltrials gov. Identi fi er: NC T03019055 ).All participants provided written informed consent and all procedures were approved in advance by the MCW Institutional Review Board.Patient income was self-reported based on household annual income as either above (high SES) or below (low SES) the 2021 Wisconsin median of$54,660. Further details are described elsewhere.This study is limited by the small sample size.These provocative findings need to be further evaluated in a largercohort wherein addnl. patient-, disease-, and CAR T- related variables can be appropriately controlled for and mediational analyses conducted.

100 Deals associated with LV20.19 CAR T cells(Medical College of Wisconsin)

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Indication	Highest Phase	Country/Location	Organization	Date
Burkitt Lymphoma	Phase 1	-	Medical College of Wisconsin	01 Jan 2025
Diffuse Large B-Cell Lymphoma	Phase 1	-	Medical College of Wisconsin	01 Jan 2025
Follicular Lymphoma	Phase 1	-	Medical College of Wisconsin	01 Jan 2025
Mantle-Cell Lymphoma	Phase 1	-	Medical College of Wisconsin	01 Jan 2025
Marginal Zone B-Cell Lymphoma	Phase 1	-	Medical College of Wisconsin	01 Jan 2025

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