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DRUG:

Yorwida (inaticabtagene autoleucel)

i
Other names: CNCT19, CNCT 19, HY001, CNCT-19, inati-cel, HY 001, HY-001
Associations
Company:
CASI, Juventas Cell Therapy
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
2ms
Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Juventas Cell Therapy Ltd. | Initiation date: Aug 2025 --> Dec 2025
Trial initiation date
|
cyclophosphamide • Yorwida (inaticabtagene autoleucel)
3ms
Long-term outcomes of CNCT19 chimeric antigen receptor T-cell therapy in relapsed or refractory aggressive B-cell lymphoma. (PubMed, Chin Med J (Engl))
CNCT19s exhibited favorable safety profiles and efficacy in patients with R/R DLBCL and FL3B. Long-term follow-up confirmed the curative potential of CNCT19s in R/R aggressive B-cell lymphoma.
Journal
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TP53 (Tumor protein P53)
|
TP53 mutation • CD19 positive
|
cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)
4ms
Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Sep 2025 --> Sep 2026
Trial primary completion date
|
cyclophosphamide • Yorwida (inaticabtagene autoleucel)
4ms
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric) (clinicaltrials.gov)
P1/2, N=47, Recruiting, Juventas Cell Therapy Ltd. | Trial completion date: Dec 2026 --> May 2027
Trial completion date
|
CD19 (CD19 Molecule)
|
cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)
4ms
Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection (clinicaltrials.gov)
P=N/A, N=1000, Recruiting, Juventas Cell Therapy Ltd. | Active, not recruiting --> Recruiting
Enrollment open
|
Yorwida (inaticabtagene autoleucel)
4ms
Enrollment open
|
cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)
7ms
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov)
P1/2, N=30, Completed, Institute of Hematology & Blood Diseases Hospital, China | Active, not recruiting --> Completed | N=20 --> 30
Trial completion • Enrollment change
|
BCL6 (B-cell CLL/lymphoma 6)
|
gemcitabine • melphalan • busulfan • Yorwida (inaticabtagene autoleucel)
10ms
New P1 trial
|
cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)
10ms
Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases (clinicaltrials.gov)
P1, N=24, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2024 --> Dec 2025
Trial primary completion date
|
cyclophosphamide • Yorwida (inaticabtagene autoleucel)
10ms
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric) (clinicaltrials.gov)
P1/2, N=47, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2024 --> Jul 2025
Trial primary completion date
|
CD19 (CD19 Molecule)
|
cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)
10ms
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P2, N=60, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2024 --> Mar 2024
Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive
|
cyclophosphamide • fludarabine IV • Yorwida (inaticabtagene autoleucel)