Status and phase
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About
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 investigational study designed as a single-center, open-label and single-arm clinical trial.
Enrollment
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Volunteers
Inclusion criteria
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:
Leukemia patient confirmed by bone marrow aspiration that has not been alleviated; lymphoma patient with measurable or assessable lesions;
Adequate organ function:
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 criteria
Subjects meeting one or more of the following criteria will be excluded:
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Yu WANG, Dr.; Guangxun GAO, Dr.
Data sourced from clinicaltrials.gov
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