Actively Recruiting
Safety and Efficacy of PRG-2302 for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.
Led by Tan Jie · Updated on 2024-10-26
18
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
T
Tan Jie
Lead Sponsor
S
Shenzhen Pregene Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Clinical Study on the Safety and Effectiveness of CD19/CD22 Chimeric Antigen Receptor T Cells in the Treatment of Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.
CONDITIONS
Official Title
Safety and Efficacy of PRG-2302 for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and not over 70 years old
- Diagnosed with recurrent or refractory B-cell acute lymphoblastic leukemia (B-ALL) meeting specific disease criteria
- Positive CD19 and/or CD22 leukemia cells in bone marrow or peripheral blood
- Primitive and naive lymphocyte proportion in bone marrow at screening is at least 5%
- Normal important organ functions including cardiac ejection fraction ≥50%, creatinine clearance ≥30 mL/min, liver enzymes ≤3 times upper limit of normal, bilirubin and alkaline phosphatase ≤2 times upper limit of normal (Gilbert syndrome ≤3 times ULN)
- Blood oxygen saturation above 92%
- Expected survival of at least 3 months
- ECOG performance status score between 0 and 2
- Willingness to sign informed consent
You will not qualify if you...
- Active central nervous system leukemia as defined by NCCN guidelines
- Other malignancies within 5 years except certain cured cancers without active disease
- Positive for hepatitis B or C with viral load above normal, HIV, syphilis, cytomegalovirus, or Epstein-Barr virus infections
- Uncontrolled active infection
- Significant central nervous system diseases like epilepsy, stroke history, cerebellar disease, organic brain syndromes, or psychosis (unless previously treated and improved)
- Organ failure: severe heart failure (NYHA III/IV), recent myocardial infarction or cardiac surgery within 6 months, severe ventricular arrhythmia, severe liver or kidney failure
- Serious or uncontrollable comorbid conditions interfering with study assessments
- Allergic reactions or intolerances to PRG2302 components or related drugs
- Donor lymphocyte infusion within 4 weeks before cell collection
- Live or attenuated vaccines within 4 weeks before cell collection or during study
- Major surgery within 4 weeks
- Recent allogeneic stem cell transplant or graft-versus-host disease requiring systemic therapy within 4 weeks
- Recent high-dose chemotherapy, intrathecal therapy, short-acting cytotoxic drugs, tyrosine kinase inhibitors, systemic glucocorticoids, or biologic drugs within specified time frames
- Pregnancy, breastfeeding without willing cessation, or refusal to use contraception if fertile
- Inability to collect sufficient mononuclear or T cells
- Participation in other intervention clinical trials within 3 months
- Other medical conditions deemed unsuitable by the investigator for treatment or study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First People's Hospital of Jingzhou
Jinzhou, Hubei, China
Actively Recruiting
Research Team
T
Tan jie
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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