Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) reviewing available safety, PK and preliminary efficacy data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CD70 UCAR-T
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDose-limiting toxicity (DLT)
Safety
Time frame: 28 days of first infusion of CHT101
Maximum tolerated dose (MTD)
Tolerability
Time frame: 28 days of first infusion of CHT101
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse events post infusion of CHT101 infusion
Time frame: 2 years
Objective response rate (ORR)
The proportion of subjects who achieve CR or PR after CHT101 infusion
Time frame: 2 years
Duration of response (DOR)
The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
Time frame: 2 years
Progression-free survival (PFS)
The period from the day when the subject receives the infusion of cells to the first recorded tumor progression or death of any cause, which occurs first
Time frame: 2 years
Overall survival (OS)
The period from the first infusion to any cause of death
Time frame: 2 years
Pharmacokinetics (PK)
Concentration levels of CHT101
Time frame: 2 years
Pharmacodynamics (PD)
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Concentration levels of cytokines
Time frame: 2 years