Study of INKmune in Patients With mCRPC (CaRe Prostate)
NCT06056791 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-02-27
Summary
This is an open-label, phase I/IIa dose escalation and expansion study of INKmune in men with mCRPC. INKmune is administered to patients intravenously over three doses, at least one-week apart. The study will consist of two stages.
Conditions
Interventions
- BIOLOGICAL
-
INKmune is a patented biologic delivery system and method for cancer treatment using in vivo priming and activation of natural killer (NK) cells in order to achieve tumor cell lysis. INKmune is a suspension of INB16 cells which have been rendered replication incompetent that does not require donor matching.
Sponsors & Collaborators
-
Inmune Bio, Inc.
lead INDUSTRY
Principal Investigators
-
Tara Lehner · INmune Bio
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-30
- Primary Completion
- 2025-09-10
- Completion
- 2025-09-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
NCT05361174 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors
NCT02350673 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors
NCT03644056 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma
NCT01026051 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma.
NCT00688090 ·Status: COMPLETED ·Phase: PHASE1
-
Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
NCT00040170 ·Status: TERMINATED ·Phase: PHASE2
-
Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy
NCT06587295 ·Status: RECRUITING ·Phase: PHASE1
-
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
NCT01993719 ·Status: COMPLETED ·Phase: PHASE2
-
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
NCT00024232 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors
NCT00747734 ·Status: COMPLETED ·Phase: PHASE1
-
IMCgp100 in Advanced Unresectable Melanoma
NCT01209676 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
NCT00016146 ·Status: COMPLETED ·Phase: PHASE1
-
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
NCT03190941 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
NCT00016237 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Drug Ipilimumab for Metastatic Merkel Cell Carcinoma
NCT01913691 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
NCT00095108 ·Status: COMPLETED ·Phase: PHASE1
-
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
NCT01174121 ·Status: RECRUITING ·Phase: PHASE2
-
A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
NCT06258304 ·Status: RECRUITING ·Phase: PHASE1
-
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients
NCT03745326 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
TIL Therapy for Metastatic Renal Cell Carcinoma
NCT02926053 ·Status: COMPLETED ·Phase: PHASE1
-
CPG 7909 Injection in Melanoma
NCT00070642 ·Status: COMPLETED ·Phase: PHASE2
-
IMC-A12 in Treating Patients With Advanced Liver Cancer
NCT00639509 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Trial of Monoclonal Antibody (J591) in Combination With Low-Dose Subcutaneous Interleukin-2
NCT00040586 ·Status: COMPLETED ·Phase: PHASE2
-
Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
NCT02650986 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer
NCT05544227 ·Status: COMPLETED ·Phase: PHASE1