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UCD19 CAR T Cells
i
Other names: UCD19 CAR T Cells, CD19CAR-CD3zeta-4-1BB-expressing allogeneic T-lymphocyte cells
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Company:
University of Colorado
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
15d
Use of CD19 CAR-T Cells in Adult B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Minimal Residual Disease (MRD) Positivity at First Complete Remission: Preliminary Outcomes from a Phase I Clinical Trial (ASH 2024)
Incorporation of blinatumomab and/or inotuzumab in CR1 may mitigate the negative prognostic significance of MRD, however it is unclear if intensity of standard post-remission therapy can be safely reduced without compromising outcomes...We designed a phase I clinical trial to determine safety and tolerability of UCD19 CAR-T cell therapy for adults with B-ALL in MRD+ CR1 who are at high risk for relapse.Methods : Eligible patients include adults (≥18yo) with B-ALL in CR1 after induction therapy, with MRD positivity by either flow cytometry or NGS (Clonoseq)...Longer follow-up is needed to determine if remissions remain durable, and to determine the relationship between functional persistence (as measured by B-cell aplasia) and remission durability. Enrollment is ongoing at DL2.
Clinical • P1 data • CAR T-Cell Therapy • Minimal residual disease
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8)
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clonoSEQ
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • UCD19 CAR T Cells
8ms
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov)
P1, N=11, Active, not recruiting, University of Colorado, Denver | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date
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CD19 (CD19 Molecule)
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CD19 positive • CD19 expression
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UCD19 CAR T Cells
12ms
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL (clinicaltrials.gov)
P1/2, N=50, Recruiting, University of Colorado, Denver
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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CD19 expression
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UCD19 CAR T Cells
1year
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov)
P1, N=11, Active, not recruiting, University of Colorado, Denver | Trial primary completion date: Dec 2023 --> Mar 2023
Trial primary completion date
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CD19 (CD19 Molecule)
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CD19 positive • CD19 expression
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UCD19 CAR T Cells
over1year
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov)
P1, N=11, Active, not recruiting, University of Colorado, Denver | Trial primary completion date: Dec 2022 --> Dec 2023
Trial primary completion date
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CD19 (CD19 Molecule)
|
CD19 positive • CD19 expression
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UCD19 CAR T Cells
over1year
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1 (clinicaltrials.gov)
P1; Not yet recruiting --> Recruiting | Trial completion date: Apr 2026 --> Jul 2027 | Initiation date: Dec 2023 --> Jul 2023 | Trial primary completion date: Apr 2025 --> Jul 2025
CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Enrollment open • Trial initiation date • Minimal residual disease
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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clonoSEQ
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UCD19 CAR T Cells
almost2years
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1 (clinicaltrials.gov)
P1, N=14, Not yet recruiting, University of Colorado, Denver | Initiation date: Dec 2022 --> Dec 2023
Trial initiation date • CAR T-Cell Therapy • Minimal residual disease
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD19 (CD19 Molecule)
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UCD19 CAR T Cells
over2years
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1 (clinicaltrials.gov)
P1, N=14, Not yet recruiting, University of Colorado, Denver
New P1 trial • CAR T-Cell Therapy • Minimal residual disease
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD19 (CD19 Molecule)
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UCD19 CAR T Cells
over2years
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov)
P1, N=11, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting | N=20 --> 11
Enrollment closed • Enrollment change
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CD19 (CD19 Molecule)
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CD19 positive • CD19 expression
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UCD19 CAR T Cells
over2years
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov)
P1, N=20, Recruiting, University of Colorado, Denver | Trial completion date: Dec 2022 --> Dec 2023
Trial completion date
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CD19 (CD19 Molecule)
|
CD19 positive • CD19 expression
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UCD19 CAR T Cells
over3years
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL (clinicaltrials.gov)
P1/2, N=50, Recruiting, University of Colorado, Denver | Trial completion date: Jul 2021 --> Jul 2026 | Trial primary completion date: Jun 2021 --> Jun 2026
Clinical • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
|
CD19 (CD19 Molecule)
|
CD19 expression
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UCD19 CAR T Cells
over3years
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov)
P1, N=20, Recruiting, University of Colorado, Denver | Trial completion date: Mar 2024 --> Dec 2022 | Trial primary completion date: Mar 2024 --> Dec 2022
Clinical • Trial completion date • Trial primary completion date
|
CD19 (CD19 Molecule)
|
CD19 positive • CD19 expression
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UCD19 CAR T Cells
almost4years
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL (clinicaltrials.gov)
P1/2, N=50, Recruiting, University of Colorado, Denver | Not yet recruiting --> Recruiting
Clinical • Enrollment open • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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CD19 expression
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UCD19 CAR T Cells
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