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DRUG:

huCART19

i
Other names: huCART19, huCTL019, huCART-19 T cell therapy, CTL119, CTL 119, CTL-119
Associations
Company:
Novartis, University of Pennsylvania
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
2ms
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL (clinicaltrials.gov)
P2, N=106, Completed, University of Pennsylvania | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Apr 2024 | Trial primary completion date: Aug 2024 --> Apr 2024
Trial completion • Trial completion date • Trial primary completion date
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CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
6ms
CAR-T Cell Therapy for Desensitization in Kidney Transplantation (clinicaltrials.gov)
P1, N=20, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting --> Recruiting
Enrollment open
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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cyclophosphamide • fludarabine IV • huCART19
7ms
CAR-T Cell Therapy for Desensitization in Kidney Transplantation (clinicaltrials.gov)
P1, N=20, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Initiation date: Mar 2024 --> May 2024
Trial initiation date • CAR T-Cell Therapy
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
|
cyclophosphamide • fludarabine IV • huCART19
11ms
Co-administration of CART22-65s and huCART19 for B-ALL (clinicaltrials.gov)
P1/2, N=93, Recruiting, Stephan Grupp MD PhD | Trial completion date: Jan 2026 --> Jan 2029 | Trial primary completion date: Jan 2025 --> Jan 2027
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
|
CD22 (CD22 Molecule)
|
CD19 expression • CD22 expression
|
CART22 • huCART19
11ms
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy) (clinicaltrials.gov)
P1/2, N=89, Recruiting, Stephan Grupp MD PhD | Trial completion date: Sep 2027 --> Sep 2029 | Trial primary completion date: Sep 2025 --> Sep 2027
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
1year
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy) (clinicaltrials.gov)
P1/2, N=89, Recruiting, Stephan Grupp MD PhD | Active, not recruiting --> Recruiting | Trial primary completion date: Sep 2023 --> Sep 2025
Enrollment open • Trial primary completion date • CAR T-Cell Therapy
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
1year
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy) (clinicaltrials.gov)
P1/2, N=89, Active, not recruiting, Stephan Grupp MD PhD | Recruiting --> Active, not recruiting
Enrollment closed • CAR T-Cell Therapy
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
over1year
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL (clinicaltrials.gov)
P2, N=100, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting | N=63 --> 100
Enrollment closed • Enrollment change
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
almost2years
Co-administration of CART22-65s and huCART19 for B-ALL (clinicaltrials.gov)
P1/2, N=93, Recruiting, Stephan Grupp MD PhD | Not yet recruiting --> Recruiting
Enrollment open • CAR T-Cell Therapy
|
CD19 (CD19 Molecule) • CD22 (CD22 Molecule) • CRP (C-reactive protein)
|
CD19 expression
|
CART22 • huCART19
almost2years
Academic Development of a Lentiviral Vector vs CD19 (EHA-EBMT-CART 2023)
The extracellular domain that we will use corresponds to the mouse monoclonal antibody that recognizes human CD19 from tisagenlecleucel®. It is feasible to develop a huCART-19 with research grade in Mexico, the next step is to evaluate its function in a clinical model.
IO biomarker • Viral vector
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CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • TNFRSF9 (TNF Receptor Superfamily Member 9)
|
Kymriah (tisagenlecleucel-T) • huCART19
almost2years
Co-administration of CART22-65s and huCART19 for B-ALL (clinicaltrials.gov)
P1/2, N=93, Not yet recruiting, Stephan Grupp MD PhD
New P1/2 trial • CAR T-Cell Therapy
|
CD19 (CD19 Molecule) • CD22 (CD22 Molecule) • CRP (C-reactive protein)
|
CD19 expression
|
CART22 • huCART19
almost2years
Anti-BCMA/CD19 CAR T cells with early immunomodulatory maintenance for multiple myeloma responding to initial or later-line therapy. (PubMed, Blood Cancer Discov)
We conducted a phase 1 clinical trial of anti-BCMA CAR T cells (CART-BCMA) with or without anti-CD19 CAR T cells (huCART19) in multiple myeloma (MM) patients responding to third- or later- line therapy (Phase A, N=10) or high-risk patients responding to first-line therapy (Phase B, N=20), followed by early lenalidomide or pomalidomide maintenance. Outcomes with CART-BCMA + huCART19 were similar to CART-BCMA alone. Collectively, our results demonstrate favorable safety, pharmacokinetics, and antimyeloma activity of dual-target CAR T cell therapy in early lines of multiple myeloma treatment.
Journal • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
|
lenalidomide • pomalidomide • huCART19
2years
Enrollment open • CAR T-Cell Therapy
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
over2years
New P1/2 trial • CAR T-Cell Therapy
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
over2years
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL (clinicaltrials.gov)
P2, N=63, Recruiting, University of Pennsylvania | Trial completion date: Aug 2022 --> Aug 2024 | Trial primary completion date: Aug 2022 --> Aug 2024
Trial completion date • Trial primary completion date
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
almost3years
Impact of high-risk cytogenetics on outcomes for children and young adults receiving CD19-directed CAR T cell therapy. (PubMed, Blood)
CTL019/huCART19/tisagenlecleucel are effective at achieving durable remissions across cytogenetic categories. Relapsed/refractory patients with high-risk cytogenetics, including KMT2A-rearranged infant ALL, demonstrated high RFS and OS probabilities at 2 years.
Clinical • Journal • CAR T-Cell Therapy
|
CD19 (CD19 Molecule) • RUNX1 (RUNX Family Transcription Factor 1) • KMT2A (Lysine Methyltransferase 2A) • ETV6 (ETS Variant Transcription Factor 6) • IKZF1 (IKAROS Family Zinc Finger 1) • TCF3 (Transcription Factor 3) • PBX1 (PBX Homeobox 1)
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MLL rearrangement • MLL rearrangement • IKZF1 deletion
|
Kymriah (tisagenlecleucel-T) • huCART19
3years
CART22-65s Co-Administered with huCART19 in Adult Patients with Relapsed or Refractory ALL (ASH 2021)
Methods : Adult patients with r/r ALL were co-administered two humanized autologous CAR T cell products, one targeted to CD19 (huCART19) and the other to CD22 (CART22-65s) after fludarabine and cyclophosphamide lymphodepletion... Of 13 treated patients (median age 46 (range 28-71)), two had received prior murine CART19 cells, 8 had prior blinatumomab, 8 had prior inotuzumab and 10 had a prior allogeneic stem cell transplant (SCT)...This syndrome was refractory to IL6 and IL1beta inhibition but ultimately responded to ruxolitinib... Co-administration and adaptive dosing of CART22-65s with huCART19 in adult patients with r/r ALL is feasible and effective. The two different products demonstrated differential expansion and persistence kinetics. Despite prior exposure to CD19- and/or CD22-specific immunotherapies, all evaluable patients achieved CR with uMRD; we continue to monitor CAR T cell persistence and its impact on durability of response.
Clinical
|
IL6 (Interleukin 6) • CD22 (CD22 Molecule) • IL1B (Interleukin 1, beta)
|
CD19 expression
|
Jakafi (ruxolitinib) • cyclophosphamide • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • fludarabine IV • CART22 • huCART19
3years
Outcomes after Reinfusion of CD19-Specific Chimeric Antigen Receptor (CAR)-Modified T Cells in Children and Young Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (ASH 2021)
Reinfusion of CTL019/tisagenlecleucel or huCART19 is safe, may prolong B-cell aplasia in patients with short CAR persistence and reduce relapse risk, and can induce remissions in patients with CD19+ relapsed disease. Thus, reinfusion may provide an alternative to HSCT for short persistence. However, reinfusion is not effective for patients with nonresponse to initial CAR infusion.
Clinical
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CD19 (CD19 Molecule)
|
Kymriah (tisagenlecleucel-T) • huCART19
3years
CD19-targeted chimeric antigen receptor T-cell therapy for CNS relapsed or refractory acute lymphocytic leukaemia: a post-hoc analysis of pooled data from five clinical trials. (PubMed, Lancet Haematol)
Tisagenlecleucel and huCART19 are active at clearing CNS disease and maintaining durable remissions in children and young adults with CNS relapsed or refractory B-cell acute lymphocytic leukaemia or lymphocytic lymphoma, without increasing the risk of severe neurotoxicity; although care should be taken in the timing of therapy and disease control to mitigate this risk. These preliminary findings support the use of these CAR T-cell therapies for patients with CNS relapsed or refractory B-cell acute lymphocytic leukaemia.
Clinical • Retrospective data • Journal • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
|
CD19 positive
|
Kymriah (tisagenlecleucel-T) • huCART19
3years
Clinical • Trial completion • Trial completion date
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
3years
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL (clinicaltrials.gov)
P2, N=63, Recruiting, University of Pennsylvania | Trial primary completion date: Aug 2021 --> Aug 2022
Clinical • Trial primary completion date
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
over3years
Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma (clinicaltrials.gov)
P1, N=40, Active, not recruiting, University of Pennsylvania | Trial primary completion date: May 2022 --> Mar 2036
Clinical • Trial primary completion date
|
SOX2
|
MTV273 • huCART19
over3years
CART22 Alone or in Combination With huCART19 for ALL (clinicaltrials.gov)
P1, N=23, Active, not recruiting, University of Pennsylvania | Trial completion date: Sep 2037 --> Jan 2036
Clinical • Trial completion date • Combination therapy
|
CD19 (CD19 Molecule) • CD22 (CD22 Molecule)
|
huCART19
over3years
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL (clinicaltrials.gov)
P2, N=63, Recruiting, University of Pennsylvania | Active, not recruiting --> Recruiting
Clinical • Enrollment open
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
over3years
Humanized CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells in CAR-Naive and CAR-Exposed Children and Young Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia. (PubMed, J Clin Oncol)
HuCART19 achieved durable remissions with long-term persistence in children and young adults with relapsed or refractory B-ALL, including after failure of prior CAR T-cell therapy.
Clinical • Journal
|
CD19 (CD19 Molecule)
|
huCART19
over3years
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL (clinicaltrials.gov)
P2, N=63, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting
Clinical • Enrollment closed
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
over3years
Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma (clinicaltrials.gov)
P1, N=40, Active, not recruiting, University of Pennsylvania | Trial primary completion date: May 2021 --> May 2022
Clinical • Trial primary completion date
|
SOX2
|
MTV273 • huCART19
almost4years
Retreatment With CTL019/CTL119 (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Abramson Cancer Center of the University of Pennsylvania | Initiation date: Nov 2020 --> Apr 2021
Clinical • Trial initiation date
|
CD19 (CD19 Molecule)
|
Kymriah (tisagenlecleucel-T) • huCART19
almost4years
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL (clinicaltrials.gov)
P2, N=85, Recruiting, University of Pennsylvania | Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Jan 2021 --> Aug 2021
Clinical • Trial completion date • Trial primary completion date
|
CD19 (CD19 Molecule)
|
CD19 expression
|
huCART19
almost4years
CART22 Alone or in Combination With huCART19 for ALL (clinicaltrials.gov)
P1, N=23, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting
Clinical • Enrollment closed • Combination therapy
|
CD19 (CD19 Molecule) • CD22 (CD22 Molecule)
|
huCART19
4years
CART22 Alone or in Combination With huCART19 for ALL (clinicaltrials.gov)
P1, N=18, Recruiting, University of Pennsylvania | Trial completion date: Sep 2033 --> Sep 2037 | Trial primary completion date: Jan 2021 --> Jan 2036
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
CD19 (CD19 Molecule) • CD22 (CD22 Molecule)
|
huCART19
4years
Retreatment With CTL019/CTL119 (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Abramson Cancer Center of the University of Pennsylvania | Initiation date: Jul 2020 --> Nov 2020
Clinical • Trial initiation date
|
CD19 (CD19 Molecule)
|
Kymriah (tisagenlecleucel-T) • huCART19