Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

In Dose Escalation: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 18 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

* In Cohort 1, the initial planned dose is 1 x 10\^8 INKmune;
* In Cohort 2, the weekly dose will increase to 3 x 10\^8 INKmune;
* In Cohort 3, the weekly dose will increase to 5 x 10\^8 INKmune.

In Dose Expansion: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 12 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below:

Following mBOIN termination and MTD identification, patients will be enrolled in up to two candidate optimal dose levels (no higher than the MTD) for final optimal dose determination.

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.

INKmune

Nicole Kay-Mindick

Matthew Rettig, MD

Kyaw Thein, MD

Abby Reed

Alexander Starodub, MD

Maya Fleyhan

Haroutioun Shahinian, MD

Pablo Villarreal

Jonathan Lu, MD

Blake Patterson

M. Adham Salkeni, MD

Robert (Bruce) Montgomery, MD

Tara Lehner

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.

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 3 doses. The 3 infusions will occur over a minimum of a 2-week period, with each infusion at least 1 week apart. The study will consist of 2 stages:

* Dose escalation: exploring dose levels of 1x10\^8, 3x10\^8, and 5x10\^8 cells per infusion.
* Dose expansion: following mBOIN termination and maximum tolerated dose (MTD) identification, patients will be enrolled in up to 2 candidate optimal dose levels for final optimal dose determination.

Eligible patients will sign informed consent prior to any study assessments being performed. Patients have up to 30 days in which to have all screening procedures and eligibility assessed. Patients will be infused with INKmune on Days 1, 8, and 15. Patients will also present to site on days 29, 57, 85, 113, and 141 to complete study assessments. Day 169 is the last study visit and patient will have completed trial after this visit has been completed. Option to enroll in the INKmune Long term Follow-up Registry will be presented at Day 169 visit.

Study of INKmune in Patients With mCRPC (CaRe Prostate)

An Open-label, Phase I/IIa Dose Escalation and Expansion Study to Determine the Safety and Clinical Activity of an Immune Priming Cell Therapy (INKmune) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Assess persistence of memory like Natural Killer (NK) cell number.

Relationship will be explored through multi-parameter flow cytometry and tumor killing of NK resistant tumor targets (RAJI cells) in blood of patients after treatment with INKmune. Disease response will be assessed from RECIST, PSMA, PSA data.

Relationship between blood PSA levels and change in tumor burden will be assessed through collection of serum PSA level and measurable disease burden assessed by RECIST v1.1, PCWG3 criteria, and Pylarify PSMA PET scan (piflufolastat F 18). PSA will be collected at Screening and at each visit following the 3 doses of INKmune. PSMA PET scans will be completed at Day 1, Day 57 and Day 169.

Relationship between ctDNA levels and treatment response will be assessed by collection of serial ctDNA assays in patients with available pre-treatment tumor DNA. ctDNA collections will occur at Day 1, Day 57 and Day 169.

Optional biopsy tissue and previously resected tissue will be analyzed with Immunohistochemistry (IHC) and RNA sequencing of patient pathological specimens.

Outcome will be evaluated by review of medical history and collection of safety follow-up visits to record mCRPC treatments after completion of clinical trial in comparison to peripheral blood activated NK cell (memory like NK cell phenotype) percentage by flow cytometry.

Quality Improvement: Assess the experience of clinical trial participation by patients through patient questionnaires collected throughout the clinical trial. Questionnaires will be provided at 3 time points during study participation following study visits.

Understand the patient experiences across participation in the clinical trial, through patient questionnaires (answers to be selected on a scale from '1 to 5', with '1' being very poor and '5' being very good), to assess patient perceptions in the following areas:

* Access,
* Communication,
* Information \& materials,
* Patient burden,
* Patient centeredness,
* Privacy,
* Quality of care,
* Trust,
* Safety.

Measurement of peripheral blood activated NK cell (memory like NK cell phenotype) percentage by flow cytometry to \>2 times pre-treatment percentage.

Measurement of Prostate Specific Antigen (PSA) to determine the percent of patients that decrease PSA by ≥30% during treatment.

Measurement of disease burden as determined by prostate-specific membrane antigen (PMSA) positron emission tomography (PET) scan.

Measurement of change in circulating tumor DNA (ctDNA).

Measurement of frequency and severity of Dose-Limiting Toxicities (DLT).

Measurement of frequency and severity of adverse events (AEs).

Measurement of frequency and severity of serious adverse events (SAEs).

Assessment based on current Prostate Cancer Working Group 3 (PCWG3) modified Response Evaluation Criteria (RECIST) Version 1.1, where applicable.

Measurement of PSA response using PSA50 response rate.

Measurement of the period of time PSA decrease by ≥30%.

Measurement of the period of time PSA is below baseline.

Measurement of Progression Free Survival (PFS).

Measurement of Radiological Progression Free Survival (rPFS).

Measurement of Objective response rate (ORR)

Inmune Bio, Inc.

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Anemia, Refractory, with Excess of Blasts

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Myelodysplastic Syndrome With Excess Blasts

INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15.

* In Cohort 1, the initial planned dose is 1 x 10\^8 INKmune;
* In Cohort 2, the weekly dose will increase to 3 x 10\^8 INKmune;
* In Cohort 3, the weekly dose will increase to 5 x 10\^8 INKmune.

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. INKumne is a replication-incompetent tumor cell line that does not require donor matching.

INMB-INB16-002 is a Phase I open-label, dose escalation study of INKmune therapy in subjects with myelodysplastic syndrome (MDS) with excess blasts without Auer rods (EB-1 or 2, or CMML 1 or 2) or subjects with acute myeloid leukaemia (AML) in complete remission.

INMB-INB16-002 is a Phase 1 open-label, dose escalation study of INKmune therapy in subjects with MDS with excess blasts without Auer rods (EB-1 or 2, or CMML 1 or 2) who have completed treatment with Azacytidine (AZA) and not achieved complete remission (CR) and who are not thought to be fit for intensive chemotherapy, or subjects with AML in complete remission (or complete remission with incomplete count recovery) unsuitable for intensive chemotherapy or allogeneic stem cell transplantation or subjects with relapsed MDS or AML post-allogeneic stem cell transplant with slowly progressive disease unsuitable for intensive chemotherapy.

Participants will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 in addition to supportive care. Three cohorts, comprised of at least 3 participants, are planned. Each participant will be screened up to 28 days prior to treatment. After participants have received all doses, they will be reviewed at Day 29 and Day 43 and then followed up with monthly clinic appointments for the following 3 months (Days 73 and 119) for clinical assessment and blood tests. Once Day 119 visit is completed this classifies end of study for the participant. The trial will end after data collection has been completed for each trial participant.

A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML

A Phase I Open-Label Dose Escalation Study Of Intravenous INKmune In Patients With Myelodysplastic Syndrome With Excess Blasts (MDS-EB-1/2 - MDS-CMML 1/2) Or Acute Myeloid Leukaemia (AML)

Assess the pharmacodynamics (PD) (proof of biology) of INKmune by analyzing NK cells obtained from peripheral blood, and bone marrow as available and to measure primed NK cells and cell kill ability using the tumour killing assay.

Identify the incidence and seriousness of AEs and their relationship (causality) to INKmune as graded by NCI CTCAE criteria v.5.0.

Identify a RP2D of INKmune. The RP2D is defined as the maximum tolerated dose (MTD) of the agent which will be defined as the dose at which the complication rate is less than 33%.

To assess the overall response rate by measuring changes in percentage blasts in PB at days 29, 43, 73, 119 and BM at day 29.

To assess the overall response rate, partial response rate or complete response rate in subjects administered INKmune using the WHO criteria by measuring changes in vital signs, electrocardiogram (ECG), and safety laboratory parameters throughout the study.

To assess the progression-free survival (PFS) time defined as time to increase in transfusion dependence and or increase in percentage blasts in Peripheral Blood (PB) and/or Bone Marrow (BM).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of INKmune in Patients With mCRPC (CaRe Prostate)	NCT06056791	Cancer Metastatic Cast... mCRPC	INKmune	18 Years -	Inmune Bio, Inc.
A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML	NCT05933070	Cancer MDS-EB Myelodysplastic... Acute Myeloid L... AML	INKmune	18 Years -	Inmune Bio, Inc.

Spots Global Cancer Trial Database for nk cell based therapy