^
Contact us to learn more about
our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Yuanruida (inaticabtagene autoleucel)
i
Other names: CNCT19, CNCT 19, HY001, CNCT-19, inati-cel, HY 001, HY-001
Contact us to learn more about our Premium Content:
News alerts, weekly reports and conference planners
Company:
CASI, Juventas Cell Therapy
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
8d
Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Zhejiang University
New P1 trial • CAR T-Cell Therapy • Metastases
|
Yuanruida (inaticabtagene autoleucel)
2ms
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 2025 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
CD19 (CD19 Molecule)
|
CD19 expression
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
2ms
Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission. (clinicaltrials.gov)
P2, N=20, Recruiting, Institute of Hematology & Blood Diseases Hospital, China
New P2 trial
|
Yuanruida (inaticabtagene autoleucel)
2ms
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: Jun 2024 --> Dec 2024
Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement • CD20 negative
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
2ms
Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia (clinicaltrials.gov)
P=N/A, N=200, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Real-world evidence • Real-world
|
Yuanruida (inaticabtagene autoleucel)
5ms
Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection (clinicaltrials.gov)
P=N/A, N=1000, Active, not recruiting, Juventas Cell Therapy Ltd.
New trial
|
Yuanruida (inaticabtagene autoleucel)
5ms
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P2, N=100, Recruiting, Juventas Cell Therapy Ltd. | Trial completion date: Mar 2024 --> Dec 2026
Trial completion date
|
CD19 (CD19 Molecule)
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
5ms
Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia (clinicaltrials.gov)
P=N/A, N=200, Not yet recruiting, Juventas Cell Therapy Ltd.
New trial • Real-world evidence • Real-world
|
Yuanruida (inaticabtagene autoleucel)
8ms
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.
New P1 trial
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
8ms
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 2023 --> Jun 2024
Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement • CD20 negative
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
9ms
CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy. (clinicaltrials.gov)
P1, N=6, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting
Enrollment open
|
Yuanruida (inaticabtagene autoleucel)
10ms
CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy. (clinicaltrials.gov)
P1, N=6, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
New P1 trial
|
Yuanruida (inaticabtagene autoleucel)
10ms
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov)
P1/2, N=20, Active, not recruiting, Zou Dehui | Recruiting --> Active, not recruiting
Enrollment closed
|
BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 rearrangement
|
gemcitabine • melphalan • busulfan • Yuanruida (inaticabtagene autoleucel)
1year
A Pivotal Study Report of CNCT19 (Inaticabtagene Autoleucel) Treatment in Adult R/R B-cell ALL in China. (EHOC 2023)
CNCT19 CAR-T cell therapy achieved a high rate of MRD-negative complete remission in adult patients with R/R B-cell ALL. Thus, with its distinct CAR structure containing a unique CD19 scFv (HI19a), CNCT19 provides effective treatment with potential long-term clinical benefits for adult patients with R/R B-cell ALL.
Clinical
|
Yuanruida (inaticabtagene autoleucel)
1year
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. | N=36 --> 60
Enrollment change
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement • CD20 negative
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
over1year
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov)
P1/2, N=20, Recruiting, Zou Dehui | Trial primary completion date: Dec 2022 --> Dec 2023
Trial primary completion date
|
BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 rearrangement
|
gemcitabine • melphalan • busulfan • Yuanruida (inaticabtagene autoleucel)
over1year
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1, N=10, Completed, Juventas Cell Therapy Ltd. | Recruiting --> Completed | N=18 --> 10 | Trial completion date: Mar 2023 --> Nov 2022
Trial completion • Enrollment change • Trial completion date
|
CD19 (CD19 Molecule)
|
CD19 expression
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
over1year
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=9, Completed, Juventas Cell Therapy Ltd. | Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Nov 2022
Trial completion • Trial completion date
|
PD-L1 (Programmed death ligand 1) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement • CD20 negative
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
over1year
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P2, N=36, Recruiting, Juventas Cell Therapy Ltd. | Trial completion date: Mar 2023 --> Sep 2025 | Trial primary completion date: Dec 2022 --> Dec 2023
Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement • CD20 negative
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
over1year
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. | Not yet recruiting --> Recruiting
Enrollment open
|
CD19 (CD19 Molecule) • IL6 (Interleukin 6)
|
CD19 expression
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
almost2years
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric) (clinicaltrials.gov)
P1/2, N=47, Not yet recruiting, Juventas Cell Therapy Ltd.
New P1/2 trial
|
CD19 (CD19 Molecule) • IL6 (Interleukin 6)
|
CD19 expression
|
cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
2years
Long-Term Activity of Combining CNCT19 with HDT/ASCT in Refractory Large B-Cell Lymphoma: Two-Year Follow-up of a Prospective Phase 1/2 Clinical Trial (ASH 2022)
Conditioning regimen of GBC/M (Gemcitabine 600 mg/m2/h, infused for 3 hours with loading bolus of 75 mg/m2, day -7, -3, busulfan 105 mg/m2, day -7 until -5, cyclophosphamide 45mg/kg or melphalan 60 mg/m2, day -3, -2) was administered once the CNCT19 product was available...Eighty-nine percent of patients had a history of refractory to first-line immunochemotherapy of R-CHOP (rituximab, cyclophosphamide, adriamycin, vincristine, prednisone) or R-DA-EPOCH (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and adriamycin), and 72% were refractory to subsequent platinum-based salvage therapy... CNCT19 could be safely administered following HDT/ASCT in patients with relapsed or refractory LBCL. The strategy of combining CAR T-cell therapy with HDT/ASCT might improve response rate and prolong survival compared to CAR T-cell therapy alone.
Clinical • P1/2 data • IO biomarker
|
TP53 (Tumor protein P53) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
TP53 mutation • TP53 deletion • BCL6 rearrangement • BCL2 rearrangement
|
gemcitabine • Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • prednisone • melphalan • busulfan • Yuanruida (inaticabtagene autoleucel)
2years
Sustained Remission and Decreased Severity of CAR T-Cell Related Adverse Events: A Pivotal Study Report of CNCT19 (inaticabtagene autoleucel) Treatment in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-Cell ALL) in China (ASH 2022)
Blinatumomab and inotuzumab ozogamicin have been approved for their higher response rate, though outcome remains unsatisfied with a median OS of 7.7 months...CNCT19 was infused 2 to 14 days after lymphodepletion with cyclophosphamide and fludarabine...While CAR T-cell treatment-associated AEs were reported in most patients, a comprehensive medical team to monitor and manage the patients significantly decreased the severity of treatment-related AEs. Thus, with its distinct CAR structure containing a unique CD19 scFv (HI19a), CNCT19 provides effective treatment with potential long-term clinical benefits for adult patients with R/R B-cell ALL.
Clinical • Adverse events • CAR T-Cell Therapy • IO biomarker
|
TP53 (Tumor protein P53) • CD19 (CD19 Molecule) • IKZF1 (IKAROS Family Zinc Finger 1) • PBX1 (PBX Homeobox 1)
|
TP53 mutation
|
cyclophosphamide • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • fludarabine IV • Yuanruida (inaticabtagene autoleucel)
2years
CNCT19 CAR T-Cell Therapy in Relapsed or Refractory B-Cell Lymphoma: Long-Term Results of a Pilot Prospective Clinical Study (ASH 2022)
Lymphodepleting chemotherapy comprising fludarabine (25~30mg/m2, day -4,-3,-2) and cyclophosphamide (350mg/m2 day -4, -2) was administrated once the CNCT19 product was available. CNCT19 cells exhibited comparable efficacy and favorable safety in patients with R/R DLBCL and FL3b. A phase 2 clinical trial (NCT04586478) of administrating CNCT19 in R/R large B-cell lymphoma and high-grade B-cell lymphoma is underway.
Clinical • CAR T-Cell Therapy • IO biomarker
|
TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
|
TP53 mutation • CD19 positive • MYC expression • MYC rearrangement • BCL2 rearrangement
|
cyclophosphamide • fludarabine IV • Yuanruida (inaticabtagene autoleucel)
over2years
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P2, N=100, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2021 --> Jul 2022
Trial primary completion date
|
CD19 (CD19 Molecule) • IL6 (Interleukin 6)
|
CD19 expression
|
Yuanruida (inaticabtagene autoleucel)
over2years
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P2, N=36, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Jun 2021 --> Dec 2022
Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement • CD20 negative
|
Yuanruida (inaticabtagene autoleucel)
almost3years
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov)
P1/2, N=20, Recruiting, Zou Dehui | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2022 --> Dec 2022
Trial completion date • Trial primary completion date
|
BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 rearrangement
|
gemcitabine • melphalan • busulfan • Yuanruida (inaticabtagene autoleucel)
almost4years
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1, N=18, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Aug 2020 --> Dec 2020
Clinical • Trial primary completion date
|
CD19 (CD19 Molecule)
|
CD19 expression
|
Yuanruida (inaticabtagene autoleucel)
almost4years
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=9, Active, not recruiting, Juventas Cell Therapy Ltd. | Recruiting --> Active, not recruiting | N=18 --> 9
Clinical • Enrollment closed • Enrollment change
|
PD-L1 (Programmed death ligand 1) • BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement
|
Yuanruida (inaticabtagene autoleucel)
almost4years
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P2, N=100, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Aug 2021 --> Dec 2021
Clinical • Enrollment open • Trial primary completion date
|
CD19 (CD19 Molecule) • IL6 (Interleukin 6)
|
CD19 expression
|
Yuanruida (inaticabtagene autoleucel)
almost4years
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P2, N=100, Not yet recruiting, Juventas Cell Therapy Ltd.
Clinical • New P2 trial
|
CD19 (CD19 Molecule) • IL6 (Interleukin 6)
|
CD19 expression
|
Yuanruida (inaticabtagene autoleucel)
4years
[VIRTUAL] Anti-CD19 CAR T-Cell (CNCT19) Infusion Following HDT/ASCT Is Safe and Effective in Patients with Relapsed/Refractory Large B-Cell Lymphoma (ASH 2020)
All patients must have received rituximab and anthracycline-containing treatment during their prior therapy. Conditioning regimen included GBC/M (gemcitabine, busulfan, and cyclophosphamide/melphalan) and BEAM (carmustine, etoposide, cytarabine, and melphalan, administered in one patient), and CNCT19 was infused on day +2, +3 or +4 following autologous stem-cell infusion...Seven patients (53.8%) received tocilizumab and two patients (15.3%) received glucocorticoids for the management of CRS... CNCT19 infusion following HDT/ASCT could be safely administered in R/R large B-cell lymphoma patients. More patients achieved sustained remission compared with those who received anti-CD19 CAR T-cell therapy alone. The preliminary results of this pilot study support further investigation of the combination of CAR T cellular immunotherapy with HDT/ASCT.
Clinical • CAR T-Cell Therapy
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 rearrangement • BCL2 rearrangement
|
gemcitabine • Rituxan (rituximab) • cytarabine • etoposide IV • carmustine • melphalan • Actemra IV (tocilizumab) • busulfan • Yuanruida (inaticabtagene autoleucel) • cyclophosphamide intravenous
4years
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P2, N=36, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement
|
Yuanruida (inaticabtagene autoleucel)
4years
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P2, N=36, Not yet recruiting, Juventas Cell Therapy Ltd.
Clinical • New P2 trial
|
BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement
|
Yuanruida (inaticabtagene autoleucel)
4years
Efficacy and safety of CD19 CAR T constructed with a new anti-CD19 chimeric antigen receptor in relapsed or refractory acute lymphoblastic leukemia. (PubMed, J Hematol Oncol)
The results presented in this study indicate that CNCT19 cells have potent anti-leukemic activities in patients with R/R B-ALL. Furthermore, our findings suggest that the percentage of CD8 naïve T cells may be a useful biomarker to predict the long-term prognosis for patients undergoing CAR T cell therapy.
Clinical • Journal
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8)
|
Yuanruida (inaticabtagene autoleucel)
over4years
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=18, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
PD-L1 (Programmed death ligand 1) • BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement
|
Yuanruida (inaticabtagene autoleucel)
Share via
