UF-KURE19 / Case Comprehensive Cancer Center, Kure.ai - LARVOL DELTA

Development and Clinical Validation of an Ultra-Fast CAR-T Manufacturing Platform Enabling Production of CAR-T Cells in Less Than 1 Day (ASH 2023) - "The product passed all release criteria for infusion and was administered to the patient after lymphodepletion with fludarabine 30mg/m2 and cyclophosphamide 500mg/m2 daily for 3 days. UF-Kure19 cells expanded robustly in the patient and peaked around day 10 (23% of circulating CD3) with a strong skewing of CD4/CD8 cells (93% CD8+ T cells on day 10)...In vitro and animal data suggest this fast-manufacturing platform leads to potent CAR-T cells. Early human testing indicates CAR-T cells generated using this novel system have clinical activity against hematologic malignancies."

CAR T-Cell Therapy • Clinical • IO biomarker • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8

Phase I Study Results of UF-Kure19, a CAR-T Product Manufactured in Less Than 1 Day, in Patients with Relapsed/Refractory Non-Hodgkin's Lymphoma (ASH 2024) - P1 | "Patients received a single dose of UF-Kure19 (17.5 million CAR-T cells) following cyclophosphamide (500 mg/m²) and fludarabine (30 mg/m²) conditioning...One patient with grade 2 CRS received tocilizumab, with both grade 2 cases resolving to grade 1 or less within one day...The second non-responder (DLBCL) had a similar T cell profile to responders but lacked detectable proliferating Ki67+ CAR+ T cells post-infusion. Overall, UF-Kure19 demonstrated high efficacy and tolerability, with the potential to address current accessibility challenges and extend CAR-T therapy's reach worldwide."

Clinical • IO biomarker • P1 data • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CCR4 • CCR7 • CD28 • CD38 • CD4 • ENTPD1 • IL7R • KLRG1

CASE2422: Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: David Wald | N=16 ➔ 46

Enrollment change • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CASE2422: Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Changchun Deng, MD | Suspended ➔ Recruiting

Enrollment open • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CASE2422: Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=16 | Suspended | Sponsor: Changchun Deng, MD | Trial completion date: Oct 2025 ➔ Apr 2026 | Recruiting ➔ Suspended | Trial primary completion date: Apr 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Trial suspension • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CASE2422: Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Changchun Deng, MD | Active, not recruiting ➔ Recruiting | N=10 ➔ 16 | Trial completion date: Apr 2025 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

VIDEO: CAR T-cell therapy made in 1 day had good safety, efficacy in phase 1 trial (Healio) - P1 | N=10 | NCT05400109 | "A new chimeric antigen receptor T-cell therapy option made in less than a day may be a new option for patients with relapsed/refractory non-Hodgkin lymphoma, according to research presented at ASH Annual Meeting and Exposition...Paolo Caimi...spoke with Healio about results from a phase 1 trial assessing the use of UF-Kure19 in 10 patients with non-Hodgkin lymphoma, which found that most patients had 'good tolerance' to treatment....'In terms of response, most patients had a response — eight out of 10 patients responded — with a good durability of responses on the patients that achieved complete remission.'"

P1 data • Non-Hodgkin’s Lymphoma

CASE2422: Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Changchun Deng, MD | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CASE2422: Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Changchun Deng, MD | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: James Michael Martin | Trial completion date: Dec 2026 ➔ Dec 2024 | Initiation date: Oct 2023 ➔ Apr 2023 | Trial primary completion date: Jun 2026 ➔ Jun 2024

Trial completion date • Trial initiation date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: James Michael Martin | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: James Michael Martin

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19