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DRUG:

CAR-20/19-T Cells

i
Other names: CAR-20/19-T Cells, CAR-20/19-T, Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains, LV20.19 CAR T-cells
Associations
Company:
Medical College of Wisconsin, Miltenyi Biomedicine
Drug class:
CD19-targeted CAR-T immunotherapy, CD20-targeted CAR-T immunotherapy
Related drugs:
Associations
7d
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL (clinicaltrials.gov)
P1, N=5, Terminated, Medical College of Wisconsin | N=24 --> 5 | Trial completion date: Jun 2026 --> Sep 2025 | Suspended --> Terminated; Low accrual
Enrollment change • Trial completion date • Trial termination
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CD20 positive
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CAR-20/19-T Cells
11ms
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (clinicaltrials.gov)
P1, N=12, Recruiting, Medical College of Wisconsin | Not yet recruiting --> Recruiting
Enrollment open
|
Jaypirca (pirtobrutinib) • CAR-20/19-T Cells
11ms
PRO00037171: CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (clinicaltrials.gov)
P1/2, N=100, Recruiting, Medical College of Wisconsin | Trial completion date: Jan 2025 --> Jun 2028 | Trial primary completion date: Jan 2025 --> Jun 2026
Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
CAR-20/19-T Cells
1year
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL (clinicaltrials.gov)
P1, N=24, Suspended, Medical College of Wisconsin | Recruiting --> Suspended
Trial suspension
|
CD20 positive
|
CAR-20/19-T Cells
over1year
PRO00037171: CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (clinicaltrials.gov)
P1/2, N=100, Recruiting, Medical College of Wisconsin | Trial completion date: Dec 2025 --> Jan 2025 | Trial primary completion date: Dec 2025 --> Jan 2025
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
|
BCL2 (B-cell CLL/lymphoma 2)
|
CAR-20/19-T Cells
over1year
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Medical College of Wisconsin | Trial completion date: Feb 2025 --> Jul 2027 | Initiation date: Apr 2024 --> Jul 2024 | Trial primary completion date: Nov 2024 --> Jul 2026
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • CAR T-Cell Therapy
|
Jaypirca (pirtobrutinib) • CAR-20/19-T Cells
2years
Fresh Versus Cryopreserved LV20.19 CAR T-Cell Therapy for Relapsed, Refractory DLBCL and Follicular Lymphoma (TCT-ASTCT-CIBMTR 2024)
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 T-Cell Therapy
|
CAR-20/19-T Cells
2years
Phase 1 Trial of LV20.19 CAR T-Cells for Relapsed, Refractory CLL and Richter's Transformation (TCT-ASTCT-CIBMTR 2024)
12 pts (86%) had disease progression on covalent BTKi and venetoclax...In terms of safety, 100% (n=14) developed CRS and 93% (n=13) required tocilizumab...Six (66%) IEC-HS pts required anakinra for management... While LV20.19 CAR T cells were efficacious in CLL and RT it was limited by high rates of IEC-HS especially among CLL pts, a phenomena not commonly seen with other histologies. 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.
P1 data • CAR T-Cell Therapy
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TP53 (Tumor protein P53)
|
Venclexta (venetoclax) • Actemra IV (tocilizumab) • CAR-20/19-T Cells • Kineret (anakinra)
2years
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Medical College of Wisconsin | Initiation date: Oct 2023 --> Feb 2024
Trial initiation date
|
Jaypirca (pirtobrutinib) • CAR-20/19-T Cells
2years
Adaptive Manufacturing of LV20.19 CAR T-Cells for Relapsed, Refractory Mantle Cell Lymphoma (ASH 2023)
Fludarabine/cyclophosphamide lymphodepletion was started during MF to facilitate fresh infusion in eligible pts...Both received only a single dose of intrathecal hydrocortisone (no systemic steroids) with resolution of neurotoxicity within 24 hours of administration... Bispecific LV20.19 CAR T-cells with adaptive MF process is feasible, safe, and efficacious for R/R MCL with ORR 100%, no Grade 3+ CRS and low rates of Grade 3+ ICANS (12%). 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 T-Cell Therapy • IO biomarker
|
TP53 (Tumor protein P53) • CD4 (CD4 Molecule)
|
TP53 deletion • CD20 expression • CD19 expression
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clonoSEQ
|
cyclophosphamide • fludarabine IV • CAR-20/19-T Cells
over2years
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL (clinicaltrials.gov)
P1, N=24, Recruiting, Medical College of Wisconsin | Trial completion date: Feb 2024 --> Jun 2026 | Trial primary completion date: Oct 2023 --> Jun 2025
Trial completion date • Trial primary completion date
|
CD20 positive
|
CAR-20/19-T Cells
over2years
PRO00037171: CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (clinicaltrials.gov)
P1/2, N=100, Recruiting, Medical College of Wisconsin | N=65 --> 100 | Trial primary completion date: Dec 2023 --> Dec 2025
Enrollment change • Trial primary completion date • CAR T-Cell Therapy
|
BCL2 (B-cell CLL/lymphoma 2)
|
CAR-20/19-T Cells