Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study.
Linghui Zhou, Weijun Fu, Shenghao Wu...
https://pubmed.ncbi.nlm.nih.gov/37192741Actively Recruiting
Early Phase 1
Age: 3Years - 75Years
All Genders
ID04532268
Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
Led by Zhejiang University · Updated on 2020-08-31
72
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
This research aims to evaluate humanized CD19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive B-cell blood cancers, including acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin's lymphoma (B-NHL). The study is an early-phase, open-label, single-center trial designed to explore the safety of different dose levels of this therapy. It enrolls two groups of patients with a total of 72 participants, focusing mainly on dose-related safety outcomes. Participants receive humanized CD19 CAR-T cells through intravenous infusion. The study uses a 3+3 dose escalation design with three dose levels to determine the appropriate dosing. There is only one treatment arm where participants get this experimental CAR-T cell therapy. The study duration includes follow-up for up to two years after infusion to monitor safety and treatment effects. During the study, participants undergo various assessments including monitoring for dose-limiting toxicities up to 28 days post-infusion and tracking adverse events for up to two years. Researchers will evaluate overall response rates, survival outcomes, quality of life, and functional scores at multiple time points over two years. The study involves regular medical evaluations, laboratory tests, and quality of life questionnaires to closely observe participants' health and treatment impact throughout the trial period.
CONDITIONS
Brief Title
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
Who Can Participate
Age: 3Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- For B-ALL: Male or female aged 3 to 70 years
- Confirmed diagnosis of CD19-positive B-ALL per NCCN guidelines
- Relapsed or refractory B-ALL meeting specified chemotherapy response or relapse conditions
- Bone marrow lymphoblasts >5% by morphology or >1% by flow cytometry
- Philadelphia-chromosome-negative or Ph-positive patients intolerant or unresponsive to TKI treatments
- For B-NHL: Male or female aged 18 to 75 years
- Confirmed diagnosis of specified B-NHL types per WHO lymphoma criteria
- Relapsed or refractory B-NHL meeting specified chemotherapy or transplant response conditions
- At least one assessable tumor lesion per Lugano 2014 criteria
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times upper normal limit, creatinine ≤ 176.8 umol/L
- Left ventricular ejection fraction (LVEF) ≥ 50%
- No active lung infection and blood oxygen saturation ≥ 92%
- Estimated survival time ≥ 3 months
- ECOG performance status 0 to 2
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of brain injury, seizures, stroke, or related neurological disorders
- Abnormal ECG with prolonged QT interval or severe heart disease
- Pregnant or breastfeeding women
- Severe active infections except mild urinary tract or bacterial pharyngitis
- Active hepatitis B or C virus infection
- Systemic steroid therapy within 2 weeks prior to screening except inhaled steroids
- Previous treatment with any CAR-T or genetically modified T cell therapies
- Creatinine > 2.5 mg/dl, ALT/AST > 3 times normal, or bilirubin > 2.0 mg/dl
- Other uncontrolled diseases unsuitable for the trial
- HIV infection
- Any condition increasing risk or interfering with study results as judged by investigator
AI-Screening
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1
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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 humanized CD19 CAR T-cells by intravenous infusion with dose escalation following a 3+3 design across 3 dose levels.
1 infusion visit and multiple monitoring visits during the first 28 days
Follow-up
Duration - Up to 2 years after infusion
Participants are monitored for safety and efficacy outcomes including adverse events, response rates, survival, and quality of life for up to 2 years after infusion.
Visits at Month 1, 3, 6, 9, 12, 18, and 24 depending on assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，College of Medicine, 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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Safety and efficacy of autologous and allogeneic humanized CD19-targeted CAR-T cell therapy for patients with relapsed/refractory B-ALL.
Fengmei Song, Yongxian Hu, Yanlei Zhang...
https://pubmed.ncbi.nlm.nih.gov/36808074