Cutaneous T-cell Lymphoma (CTCL), NHL (Non-Hodgkin Lymphoma), Peripheral T-cell Lymphoma
Conditions
Brief summary
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
Detailed description
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.
Interventions
DRUGCHT101
CD70 UCAR-T
Sponsors
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(abbreviated): 1. Willing and able to provide written informed consent. 2. Aged 18 to 70 years, male or female. 3. Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC). 4. Only the following subtypes of hematological malignancies with measurable disease will be enrolled: 1. 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. 2. Cutaneous T cell lymphoma (including mycosis fungoides (MF) or Sézary syndrome (SS) \[stage ≥IIB with disease involving two or more compartments or single-compartment disease with large-cell transformation\]) who have failed ≥2 lines of systemic therapies. 3. Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines. 4. Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody. 5. Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. Estimated life expectancy ≥12 weeks. 7. Female patients of childbearing potential and male patients must agree to use a highly effective method of contraception from signing ICF through 2 years after last CHT101 infusion.
Exclusion criteria
(abbreviated): 1. History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc. 2. History of solid organ transplantation. 3. Prior treatment with CD70-targeting agents. 4. Prior treatment with CAR-T or other cellular/gene therapies. 5. Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives. 6. Active autoimmune disease requiring immunosuppression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | 28 days of first infusion of CHT101 | Safety |
| Maximum tolerated dose (MTD) | 28 days of first infusion of CHT101 | Tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | 2 years | 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) | 2 years | 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 |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 2 years | Adverse events post infusion of CHT101 infusion |
| Pharmacokinetics (PK) | 2 years | Concentration levels of CHT101 |
| Pharmacodynamics (PD) | 2 years | Concentration levels of cytokines |
| Overall survival (OS) | 2 years | The period from the first infusion to any cause of death |
| Objective response rate (ORR) | 2 years | The proportion of subjects who achieve CR or PR after CHT101 infusion |
Countries
China
Contacts
Primary ContactHuilai Zhang
Outcome results
None listed