Status:
UNKNOWN
NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
T-Cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
6-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of T-cell acute lymphoblastic leukemia (T-ALL): multi-antigen-targeted chimeri...
Detailed Description
Minimal residual disease (MRD) monitoring is currently performed in T-ALL patients to evaluate treatment response and define risk stratification. Patients with good prognosis have undetectable MRD lev...
Eligibility Criteria
Inclusion
- Age older than 6 months.
- High-burden (≥ 30% blast cells) bone marrow sample for NGS TCR clonal identification and CTL/DC vac preparation is required
- Expression of CD7, CD5, CD317, CD47, CD99, CD38 or TRBC1/2 is determined in malignant cells by flow cytometry or immuno-histochemical staining.
- Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0 mg/dL.
- Hgb ≥ 80g/L.
- No cell separation contraindications.
- Abilities to understand and the willingness to provide written informed consent.
Exclusion
- Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
- Active bacterial, fungal or viral infection not controlled by adequate treatment.
- Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Pregnant or nursing women may not participate.
- History of glucocorticoid for systemic therapy within the week prior to entering the test.
- Previous treatment with any gene therapy products.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05277753
Start Date
March 15 2022
End Date
December 31 2025
Last Update
March 15 2022
Active Locations (1)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000