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Jonatan Dewulf, Tal Flieswasser, Tim Delahaye...
https://pubmed.ncbi.nlm.nih.gov/37093350Actively Recruiting
Early Phase 1
All Genders
ID04662294
Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
Led by Zhejiang University · Updated on 2021-11-04
108
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
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-Hodgkin's 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 therapy's impact over time.
CONDITIONS
Brief Title
CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of CD70 positive Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma according to relevant clinical guidelines
- Relapsed or refractory disease meeting specified conditions for each cancer type
- Adequate organ function: total bilirubin 64 51 umol/L, ALT and AST 64 3 times upper limit of normal, creatinine 64 176.8 umol/L
- Left ventricular ejection fraction (LVEF) 65 50% by echocardiogram
- No active lung infection and blood oxygen saturation indoors 65 92%
- Estimated survival time of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Patients or legal guardians voluntarily agree to participate and sign informed consent
You will not qualify if you...
- History of brain injury, unconsciousness, epilepsy, or cerebrovascular diseases
- Prolonged QT interval on ECG or severe heart diseases like severe arrhythmia
- Pregnant or breastfeeding women
- Severe active infections except simple urinary tract infection or bacterial pharyngitis
- Active hepatitis B or C virus infection
- Systemic steroid therapy within 2 weeks prior to screening, except inhaled steroids
- Prior treatment with any CAR-T or genetically modified T cell therapies
- Creatinine above 2.5 mg/dl or liver enzymes and bilirubin above specified levels
- Other uncontrolled diseases unsuitable for the trial
- HIV infection
- Any condition that may increase risk or interfere with study results as judged by investigator
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
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Research Team
H
He Huang, PhD
Y
Yongxian Hu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/35468680