Spots Global Cancer Trial Database for Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

Study Description

Brief Summary: This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.

Detailed Description: This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia. Primary objectives: Determine the safety and tolerability of ssCART-19 cells in patients with refractory or relapsed acute lymphoblastic leukemia. Secondary objectives: 1. Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia. * Overall remission rate (ORR) assessment during the 3 months after ssCART-19 administration，ORR includes CR and CRi * Duration of response (DOR) * Progression-free survival (PFS) * Overall survival (OS) 2. To characterize the in vivo cellular pharmacokinetic (PK) profile of ssCART-19 cells. 3. To characterize the pharmacodynamic (PD) profile of ssCART-19 cells.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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