S101

P2, N=38, Not yet recruiting, Hebei Senlang Biotechnology Inc., Ltd.

We compared infection rates and immune cell subsets in 60 R/R T-ALL/LBL patients receiving naturally selected CD7 CAR-T (NS7CAR-T) with 60 R/R B-ALL patients undergoing CD19 CAR-T...This study indicates that while CD7 CAR-T therapy significantly reduces CD7(+) T cells, it does not lead to increased short-term infection rates. The notable expansion of non-CAR-T-derived CD7(-) T and NK cells helps preserve immune function, highlighting distinct therapeutic mechanisms between CD7 CAR-T and CD19 CAR-T due to their different lineage restrictions.

This trial underscores the potential promising treatment of dVHH NS7CAR-T in providing clinical benefits with a manageable safety profile to CD7-positive AML patients, warranting further investigation. NCT04938115.

P=N/A, N=50, Completed, Hebei Senlang Biotechnology Inc., Ltd. | Recruiting --> Completed | Trial completion date: Jun 2023 --> Oct 2023

SENL101 expanded robustly but persisted shortly, which on the other hand, contributed to the recovery of CD7 + T and NK cells, thereby reducing the risk of infection. An expanded cohort is warranted to verify the long-term benefit of SENL101 for T-cell malignant patients.

P1, N=9, Recruiting, Hebei Senlang Biotechnology Inc., Ltd.

P=N/A, N=100, Active, not recruiting, Hebei Senlang Biotechnology Inc., Ltd. | Recruiting --> Active, not recruiting

P=N/A, N=100, Recruiting, Hebei Senlang Biotechnology Inc., Ltd.

P1, N=18, Recruiting, Hebei Senlang Biotechnology Inc., Ltd.

More patients and longer follow-up are needed for validation. Clinical Trial can be found at NCT04572308, https://clinicaltrials.gov/.

Prior to the CAR-T cells infusion, patients received systemic bridging chemotherapy due to rapid disease progression and then all patients received intravenous fludarabine (30mg/m 2 /d) and cyclophosphamide (300mg/m 2 /d) (FC) lymphodepleting chemotherapy for 3 consecutive days (Day -5 to Day -3)...Conclusion This study demonstrated that CD7-targeted CAR-T therapy offers an opportunity to achieve CR for CD7-positive MPAL patients even for those who relapsed post-transplant. Safety was manageable, however, more data on additional patients and longer observation times are needed to further evaluate the efficacy of CD7 CAR-T products.

Prior to the CAR-T cells infusion, patients received systemic bridging chemotherapy due to rapid disease progression and then all patients received intravenous fludarabine (30mg/m 2 /d) and cyclophosphamide (300mg/m 2 /d) (FC) lymphodepleting chemotherapy for 3 consecutive days (Day -5 to Day -3)...Conclusion This study demonstrated that CD7-targeted CAR-T therapy offers an opportunity to achieve CR for CD7-positive MPAL patients even for those who relapsed post-transplant. Safety was manageable, however, more data on additional patients and longer observation times are needed to further evaluate the efficacy of CD7 CAR-T products.