Therapeutic T cell engineering.
Michel Sadelain, Isabelle Rivière, Stanley Riddell
https://pubmed.ncbi.nlm.nih.gov/28541315Actively Recruiting
Phase 1
Phase 2
Age: 3Years - 75Years
All Genders
ID06720324
An Open-label Clinical Study on the Safety and Efficacy of CD7-specific CAR-T Cell Injection for CD7-positive Relapsed or Refractory Hematologic Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-12-06
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD7-specific CAR-T cell therapy in patients with CD7-positive relapsed or refractory hematologic tumors. This open, single-center study is designed to monitor how these specially engineered immune cells behave and work in treating difficult blood cancers, while also collecting data on the treatment's pharmacokinetics and pharmacodynamics. Participants receive a preparatory treatment called lymphodepletion using fludarabine and cyclophosphamide given over three days before receiving an infusion of CD7-specific CAR-T cells at a dose of 1 to 3 million cells per kilogram of body weight. The CAR-T cells are specially engineered to avoid self-destruction by removing CD7 protein from T cells. This process enables the CAR-T cells to target cancer cells more effectively. The treatment and monitoring occur in an open-label setting without blinding. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects within three months and evaluating the overall response to the therapy over three years. Researchers will also track how the CAR-T cells expand and survive in the body. Participants will have tests to evaluate blood, organ function, and cancer status, along with safety checks. The study aims to provide detailed information on the therapy's impact over a long follow-up period lasting up to three years after infusion.
CONDITIONS
Brief Title
CD7-specific CAR-T Cell in the Treatment of CD7-positive Relapsed/Refractory Hematologic Tumors
Who Can Participate
Age: 3Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory hematologic malignancies with either recurrence or refractory status as defined
- Tumor cells expressing CD7 confirmed by bone marrow flow cytometry or pathological immunohistochemistry
- Peripheral blood tumor cells must be CD4 and CD8 negative or less than or equal to 1% if not
- Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
- Expected survival longer than 3 months
- Liver, kidney, and cardiopulmonary functions within specified limits including serum creatinine, left ventricular ejection fraction, oxygen saturation, and bilirubin and liver enzymes
- Voluntary participation with signed informed consent
You will not qualify if you...
- Recent or significant cardiac conditions such as atrial fibrillation, recent myocardial infarction, prolonged QT syndrome, low LVSF or LVEF, significant pericardial effusion, or advanced cardiac insufficiency
- Active graft-versus-host disease (GVHD)
- History of severe lung function impairment
- Advanced stage of other malignant tumors
- Uncontrolled or persistent severe infections
- Severe autoimmune diseases or innate immune deficiencies
- Active hepatitis B or C infection with abnormal liver function
- HIV or syphilis infection
- Severe allergies to biological products
- Central nervous system disorders like uncontrolled epilepsy, stroke, dementia, or cerebellar diseases
- Pregnancy, breastfeeding, or plans to become pregnant within 12 months
- Any other conditions that may increase risk or interfere with study results as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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)
Run-in Period
Duration - 3 days
Participants receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide before the CAR-T cell infusion.
3 visits (in-person) on days -5, -4, and -3
Treatment
Duration - 1 day
Participants receive a single infusion of CD7-specific CAR-T cells to treat their relapsed or refractory hematologic tumors.
1 infusion visit (in-person) on day 0
Follow-up
Duration - Up to 3 years
Participants are monitored for safety, efficacy, and CAR-T cell persistence after treatment.
Regular visits for monitoring during the 3-year follow-up period
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
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Research Team
M
Mei Heng, M.D., Ph.D
Y
Yun Kang
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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