Relapsed/Refractory Hematologic Malignancies
Conditions
Brief summary
This is an investigator-initiated, single-center, dose-escalation and dose-expansion early-phase clinical study to evaluate the safety and efficacy of iMagic Injection in participants with hematologic malignancies. The study consists of two cohorts: Cohort 1 enrolls participants with relapsed/refractory B-cell non-Hodgkin lymphoma, and Cohort 2 enrolls participants with relapsed/refractory multiple myeloma. Eligible participants in each cohort will receive infusions of iMagic Injection (IMV101 for lymphoma, IMV102 for myeloma). Blood and urine samples will be collected from participants before and after infusion for assessment of pharmacokinetics, pharmacodynamics, immunogenicity, safety, and other relevant evaluations.
Interventions
BIOLOGICALiMagic Injection (IMV101)
Eligible patients with relapsed/refractory non-Hodgkin lymphoma will receive an infusion of iMagic Injection (IMV101) , and the safety and efficacy ofiMagic Injection (IMV101) will be evaluated within 24 months post-infusion.
BIOLOGICALiMagic Injection (IMV102)
Eligible patients with relapsed/refractory multiple myeloma will receive an infusion of iMagic Injection (IMV102) , and the safety and efficacy of iMagic Injection (IMV102) will be evaluated within 24 months post-infusion.
Sponsors
Suzhou Immunofoco Biotechnology Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Participants voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up. 2. 18\~80 years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. With evaluable tumor lesion. 5. Relapsed and/or refractory hematologic malignancies (Non-Hodgkin Lymphoma or Multiple Myeloma). 6. Life expectancy≥ 3 months. 7. Clinical laboratory values meet screening visit criteria. 8. Adequate organ function.
Exclusion criteria
1. Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy. 2. Prior antitumor therapy with insufficient washout period. 3. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator). 4. Lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of iMagic injection in patients with relapsed/refractory hematologic malignancies | 24 months post iMagic injection infusion | Incidence of adverse events and its severity after iMagic injection treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pharmacokinetic (about Cmax) | 24 months post iMagic injection infusion | The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax) |
| Assessment of pharmacokinetic (about Tmax) | 24 months post iMagic injection infusion | The time to reach the maximum concentration (Tmax) |
| Efficacy of iMagic injection | about 2 years | Overall response rate after iMagic injection infusion |
Countries
China
Contacts
CONTACTNing Li
Outcome results
None listed