Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
Willing and able to provide written informed consent.
Aged 18 to 70 years, male or female.
Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
Peripheral T cell lymphoma (including peripheral T cell lymphoma NOS, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, etc.) who have failed ≥1 line of systemic therapy.
History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
History of solid organ transplantation.
Prior treatment with CD70-targeting agents.
Prior treatment with CAR-T or other cellular/gene therapies.
Single group
CHT101
DrugCD70 UCAR-T
Dose-limiting toxicity (DLT)
Safety
Maximum tolerated dose (MTD)
Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse events post infusion of CHT101 infusion
Objective response rate (ORR)
The proportion of subjects who achieve CR or PR after CHT101 infusion
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
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
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Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
Collaborator
