Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
45 participants
INTERVENTIONAL
2016-10-31
2020-01-31
Brief Summary
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Detailed Description
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Primary objectives:
1. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD19 lentiviral vector (referred to as "CAR-CD19 T" cells).
2. Determine the duration of in vivo survival of CAR-CD19 T cells.
Secondary objectives:
1. For patients with detectable disease, measure anti-tumor response due to CAR-CD19 T cells infusions.
2. To determine the amplification and survival of CAR-CD19 T 4-1BB:CD3ζ and CD28:CD3ζ as measured by the relative engraftment levels of CAR-CD19 T 4-1BB:CD3ζ and CD28:CD3ζ cells over time.
3. Estimate relative trafficking of CAR-CD19 T cells to tumors in bone marrow and lymphnodes.
4. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable CAR-CD19 T (loss of engraftment).
5. Determine the relative subsets of CAR-CD19 T cells.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-CD19 T cells
Autologous T Cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day -9 - Day -4.
CAR-CD19 T cells
Initial dose: A total of 1 - 10×10\^7 CAR-CD19 T cells/kg will be administered by 1 - 3 infusions. Subsequent dose will be based on the subject's response to initial dose.
Fludarabine
30 mg/m\^2/day×4 days
Cyclophosphamide
500 mg/m\^2/day×2 days
Interventions
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CAR-CD19 T cells
Initial dose: A total of 1 - 10×10\^7 CAR-CD19 T cells/kg will be administered by 1 - 3 infusions. Subsequent dose will be based on the subject's response to initial dose.
Fludarabine
30 mg/m\^2/day×4 days
Cyclophosphamide
500 mg/m\^2/day×2 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patients aged between 18 \~ 65 with malignant B cell leukemia and lymphoma.
2. CD19-positive B cell leukemia or lymphoma.
3. Expected survival \> 12 weeks.
4. ECOG scores 0-1, or KPS scores \> 80.
5. Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
6. WBC ≥ 2.5×109/L; LY ≥ 0.7×109/L; LY% ≥ 15%.
7. Creatinine ≤ 2.0 mg/dL (176.8 μmol/L).
8. ALT/AST ≤ 2.5 ULN.
9. Bilirubin ≤ 2.0 mg/dL (34.2 μmol/L).
10. Prothrombin Time (PT) : International Normalized Ratio (INR) \< 1.7, or PT is at most 4 s longer than normal value.
All tests results should comply with the above criteria. No continuing supportive care is received.
Exclusion Criteria
3\. Pregnant or lactating women. (The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.) 4. Active hepatitis B or hepatitis C infection. 5. HIV/AIDS infection. 6. Uncontrolled active infection. 7. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
8\. Previously treatment with any gene therapy products. 9. Allergy to immunotherapy and associated drugs. 10. Patients with heart disease that is in need of treatment or with poorly controlled hypertension determined by investigators.
11\. Patients with unstable or active ulceration or with gastrointestinal bleeding.
12\. Patients with previous or planed organ transplantation. 13. Hyponatremia with concentration of sodium in the blood \< 125 mmol/L. 14. Serum potassium (baseline) \< 3.5 mmol/L (Patients can take potassium supplements to recover serum potassium level prior to participating the study).
15\. Patients need anticoagulant (e.g. Warfarin or heparin). 16. Patients need long-term antiplatelet agent (Aspirin, dose \> 300 mg/d; Clopidogrel, dose \> 75 mg/d).
17\. Any radiotherapy conducted within 4 weeks prior to blood sampling.
18 Years
65 Years
ALL
No
Sponsors
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CARsgen Therapeutics Co., Ltd.
INDUSTRY
RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Fangyuan Chen, MD
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Other Identifiers
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CG3001
Identifier Type: -
Identifier Source: org_study_id
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