Yuanruida (inaticabtagene autoleucel)

P1, N=24, Recruiting, Juventas Cell Therapy Ltd.

P2, N=60, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2023 --> Jun 2024

P1, N=6, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting

P1, N=6, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

P1/2, N=20, Active, not recruiting, Zou Dehui | Recruiting --> Active, not recruiting

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.

P2, N=60, Recruiting, Juventas Cell Therapy Ltd. | N=36 --> 60

P1/2, N=20, Recruiting, Zou Dehui | Trial primary completion date: Dec 2022 --> Dec 2023

P1, N=9, Completed, Juventas Cell Therapy Ltd. | Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Nov 2022

P1, N=10, Completed, Juventas Cell Therapy Ltd. | Recruiting --> Completed | N=18 --> 10 | Trial completion date: Mar 2023 --> Nov 2022

P2, N=36, Recruiting, Juventas Cell Therapy Ltd. | Trial completion date: Mar 2023 --> Sep 2025 | Trial primary completion date: Dec 2022 --> Dec 2023

P1/2, N=47, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting

P1/2, N=47, Not yet recruiting, Juventas Cell Therapy Ltd.

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.

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.

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.

P2, N=36, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Jun 2021 --> Dec 2022

P2, N=100, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2021 --> Jul 2022

P1/2, N=20, Recruiting, Zou Dehui | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2022 --> Dec 2022

P1, N=18, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Aug 2020 --> Dec 2020

P1, N=9, Active, not recruiting, Juventas Cell Therapy Ltd. | Recruiting --> Active, not recruiting | N=18 --> 9

P2, N=100, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Aug 2021 --> Dec 2021

P2, N=100, Not yet recruiting, Juventas Cell Therapy Ltd.

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.

P2, N=36, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting

P2, N=36, Not yet recruiting, Juventas Cell Therapy Ltd.

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.

P1, N=18, Recruiting, Juventas Cell Therapy Ltd. | Not yet recruiting --> Recruiting