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Early Phase 1
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ID04662294

Safety and Effectiveness Study of CD70 CAR T-cell Therapy for Patients with CD70 Positive Blood Cancers including AML, NHL, and MM

Led by Zhejiang University · Updated on 2021-11-04

108

Participants Needed

1

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating CD70 CAR T-cell therapy for patients with CD70 positive malignant hematologic diseases, including Acute Myeloid Leukemia AML, Non-Hodgkins Lymphoma NHL, and Multiple Myeloma MM. This single arm, open-label study aims primarily to explore the safety of the treatment, especially focusing on dose-related safety, enrolling 108 patients based on prior clinical trials of similar products. Participants receive CD70 CAR T-cells through intravenous infusion. The study monitors dose-limiting toxicity up to 28 days after infusion and tracks treatment-emergent adverse events for up to 2 years. Secondary outcomes include overall response rates, overall survival, event-free survival at several time points up to 2 years, and assessments of quality of life, daily living activities, and mental health using standardized scales. During the study, participants undergo regular assessments including laboratory tests, echocardiograms, and evaluations of physical and mental health at baseline and multiple intervals up to two years. Researchers carefully monitor safety and treatment effects, with outcome measurements scheduled at months 1, 3, 6, 9, 12, 18, and 24. The total participation duration includes these ongoing evaluations to understand the therapys impact over time.

CONDITIONS

Brief Title

CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Research Team

H

He Huang, PhD

Y

Yongxian Hu, PhD

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