CAR-T Cells Targeting Immune Checkpoint Pathway Players.
Vita Golubovskaya
https://pubmed.ncbi.nlm.nih.gov/35468680/Actively Recruiting
Led by Zhejiang University · Updated on 2021-11-04
108
Participants Needed
1
Research Sites
156 weeks
Total Duration
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
CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
H
He Huang, PhD
Y
Yongxian Hu, PhD
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Zhejiang University
Lead Sponsor
Yake Biotechnology Ltd.
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after infusion
Participants receive CD70 CAR T-cells by intravenous infusion to treat their CD70 positive malignant hematologic disease.
1 infusion visit
Duration - Up to 2 years
Participants are monitored for safety, treatment response, and quality of life for up to 2 years after infusion.
Visits at Month 1, 3, 6, 9, 12, 18, and 24
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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Vita Golubovskaya
https://pubmed.ncbi.nlm.nih.gov/35468680/Jonatan Dewulf, Tal Flieswasser, Tim Delahaye...
https://pubmed.ncbi.nlm.nih.gov/37093350/Zhejiang University
Lead Sponsor
Yake Biotechnology Ltd.
Collaborating Sponsor