Actively Recruiting
Autologous Hematopoietic Stem Cell Boost Study After CAR-T Therapy
Led by Ruijin Hospital · Updated on 2024-10-23
18
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, open study to observe the efficacy and safety of the CART-SCB regimen (Clinical Regimen for the Prospective Study of Autologous Hematopoietic Stem Cell Boost for the Improvement of Bone Marrow Suppression in Patients with High-Risk Immunohematologic Toxicity Lymphoma After Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy Therapy) . After the patient has completed CAR-T therapy, if the patient has unrelieved hematologic toxicity, consider infusing a reserve of stem cells; if myelosuppression has not been significantly relieved, stem cell infusion can be performed again.
CONDITIONS
Official Title
Autologous Hematopoietic Stem Cell Boost Study After CAR-T Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older and gender-neutral
- Diagnosed with B-cell non-Hodgkin lymphoma confirmed histologically or cytologically according to WHO 2016 criteria
- Prior CAR-T cell immunotherapy
- High risk based on CAR-HEMATOTOX score before leukapheresis or clinically considered potentially high risk for hematologic toxicity after immunotherapy (including age 60 years, ECOG performance status 6 2, or 6 2 prior therapy lines)
- Myelosuppression after CAR-T therapy as judged by investigator
- Have stored stem cells
- Stable lymphoma disease status (complete or partial response as assessed by investigator)
- Bone marrow biopsy rules out hemophilia, infection, or bone marrow infiltration
- Adequate organ function
- Able to provide written informed consent and comply with study requirements
- Patients of childbearing potential agree to use effective contraception during study and for 120 days after last treatment
You will not qualify if you...
- History of allogeneic hematopoietic stem cell transplantation
- History of epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or central nervous system autoimmune disease
- Other malignancies within past 2 years except certain cured or superficial cancers
- Severe cardiovascular disease including grade II or higher ischemia or infarction, uncontrolled arrhythmias, grade III-IV cardiac insufficiency, or LVEF less than 50%
- Allergy to investigational drugs or excipients
- Active autoimmune disease or history of allograft transplant or prolonged heavy hormone/immune-modulating agent use affecting study treatment
- Active infection
- History of uncontrolled systemic diseases like diabetes, hypertension, or acute lung disease
- Known HIV infection
- Underlying medical conditions or substance abuse interfering with treatment or results
- End-organ damage from autoimmune disease within past 2 years or need for systemic immunosuppression or disease control medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
W
Weili Zhao, Doctor
CONTACT
L
Lingshuang Sheng, Doctor
CONTACT
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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