Status:
UNKNOWN
CRISPR (HPK1) Edited CD19-specific CAR-T Cells (XYF19 CAR-T Cells) for CD19+ Leukemia or Lymphoma.
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Xi'An Yufan Biotechnology Co.,Ltd
Conditions:
Leukemia Lymphocytic Acute (ALL) in Relapse
Leukemia Lymphocytic Acute (All) Refractory
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a first-in-human trial proposed to test CD19-specific CAR-T cells with edited endogenous HPK1 (XYF19 CAR-T cells) in patients with relapsed or refractory CD19+ leukemia or lymphoma. This is an...
Eligibility Criteria
Inclusion
- Subject must meet all the following criteria to be selected:
- Willing to provide consent/assent for participation in the study by patient or his/her legal guardian;
- Male or Female subjects age ≥18 and ≤55 years;
- Evidence of relapsed/refractory CD19+ B cell hematological malignancies. The most common relapsed/refractory B cell hematological malignancies include: (1) B cell acute lymphoblastic leukemia (B-ALL); (2) B cell lymphomas, including indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL) and aggressive B cell lymphoma (DLBCL, BL, MCL)；
- Subjects (20 subjects of B cell acute lymphoblastic leukemia and 20 subjects of B cell lymphoma) with the following conditions:
- Failure to achieve complete remission (CR) after at least two lines of standard chemotherapy while not suitable for HSCT (auto/allo-HSCT)；
- Relapse after CR, but not eligible for HSCT (auto/allo-HSCT);
- Failure to achieve remission or relapse after HSCT;
- Leukemia patient confirmed by bone marrow aspiration that has not been alleviated; lymphoma patient with measurable or assessable lesions;
- Adequate organ function:
- Liver: ALT/AST ≥ 3 × ULN, total bilirubin ≤34.2 mol/L;
- Kidney: Creatinine\<220 µmol/L, creatinine clearance rate (CCR) ≥ 60 mL/min;
- Lung: arterial oxygen saturation ≥95%;
- Heart: Left ventricular ejection fraction (LVEF) ≥40%;
- Absolute lymphocyte count (ALC) ≥ 100/μL, absolute neutrophil count (ANC) ≥ 1,000/μL, platelets (PLT) ≥ 75,000/μL;
- No prior anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (immunosuppression) within 4 weeks prior to enrollment, and toxic reactions of all prior treatments recovered to grade ≤1 at the time of enrollment (except for low toxicity such as alopecia);
- Presence of smooth peripheral superficial venous blood flow to fulfill intravenous infusion;
- Karnofsky performance score ≥60; ECOG ≤2; estimated survival ≥3 months.
Exclusion
- Subjects meeting one or more of the following criteria will be excluded:
- Female patient who is pregnant or breastfeeding ;
- Male or Female patient within Pregnancy Program in 1 year;
- Unwilling or unable to guarantee effective contraceptive measures (condoms or contraceptives) within 1 year after enrollment;
- Presence of uncontrolled infectious disease within 4 weeks prior to enrollment:
- Active hepatitis B or hepatitis C infection;
- HIV infection;
- Active TB;
- Presence of active malignancy other than disease under study, confirmed by pathology;
- Severe autoimmune diseases or immunodeficiency;
- Suffering from allergies;
- Joining another clinical trial within 6 weeks prior to enrollment;
- Using systemic corticosteroid within 4 weeks prior to enrollment (except for those who use inhaled steroids);
- Psychiatric disorders;
- History of epilepsy and seizures or other CNS pathology;
- Addiction to or abuse of drugs;
- Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04037566
Start Date
August 1 2019
End Date
August 1 2024
Last Update
July 30 2019
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shannxi, China, 710032