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UnknownNCT04825496

Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
18 (estimated)
Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
GENETICssCART-19 CellsSplit-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.
DRUGFludarabineFludarabine is used for lymphodepletion.
DRUGCyclophosphamideCyclophosphamide is used for lymphodepletion.

Timeline

Start date
2021-04-09
Primary completion
2023-12-31
Completion
2024-12-31
First posted
2021-04-01
Last updated
2023-09-21

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04825496. Inclusion in this directory is not an endorsement.