Recruiting
18+ years
Male or Female
NCT04180215

A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

Northern America
  • O'Neal Comprehensive Cancer Center at UAB
  • Banner MD Anderson Cancer Center
  • USC/Norris Comprehensive Cancer Center
  • Sylvester Comprehensive Cancer Center
  • University of Chicago Medical Center
  • University of Kansas Medical Center
  • Henry Ford Hospital
  • Washington University School of Medicine
  • Montefiore-Einstein Center for Cancer Care
  • Memorial Sloan Kettering Cancer Center
This is an First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion
Recruiting
18+ years
Male or Female
NCT05289193

CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma

Northern America
  • Memorial Sloan Kettering Cancer Center
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes
Recruiting
50+ years
Male or Female
NCT03853187

Imaging Tumor-infiltrating T-cells in Non-small Cell Lung Cancer (Donan)

Netherlands
  • Radboud University Medical Center
This is an interventional study, to assess feasibility and safety of durvalumab (MEDI4736) in neo-adjuvant setting in patients with resectable NSCLC. Additional analyses of potential imaging biomarkers, e.g. Zr-89 labelled durvalumab (MEDI4736), ex vivo In-111-oxine labelled CD8+ T-cells and high-resolution immune cell imaging, in relation to immunotherapy induced immune responses on quantitative immune histochemical analysis of the resected tumor specimen, will be performed.
Recruiting
18+ years
Male or Female
NCT05371132

An Investigational Scan (Zirconium Zr 89-Df-crefmirlimab PET) to Study the Effect of Radiation Therapy on CD8 Positive T Cells

Northern America
  • City of Hope National Medical Center
This phase I trial investigates the effect of radiation therapy on the immune system, specifically CD8 positive (+) T cells. CD8+ T cells are mainly found in lymph tissue and play a significant role in anti-tumor immunity. These cells can infiltrate tumor cells and kill them. Radiation therapy may recruit CD8 T cells and this recruitment may help with tumor control. Diagnostic procedures, such as zirconium Zr 89-Df-crefmirlimab positron emission tomography (PET), may be a less invasive way to check and monitor for CD8+ T cells before and after radiation therapy
Recruiting
18+ years
Male or Female
NCT05279027

CD8+ PET Companion Trial

Northern America
  • University of Pennsylvania
Study of 89Zr-Df-IAB22M2C PET/CT as an imaging biomarker for assessing an early response to therapy in patients with advanced melanoma on immunotherapy and hydroxychloroquine. This study is a companion study to the "LIMIT Melanoma Trial." Patients with melanoma who are potentially eligible for the LIMIT Melanoma Trial and have at least one site of measurable disease based on RECIST 1.1 are potentially eligible. Associations with progression-free survival (PFS) and overall survival (OS) will be tested.
Recruiting
18+ years
Male or Female
NCT05013099

Study of 89Zr-Df-crefmirlimab PET/CT in Subjects With Advanced or Metastatic Malignancies (iPREDICT)

Northern America
  • CARTI Cancer Center
  • Hoag Memorial Hospital Presbyterian
  • Washington University School of Medicine
The purpose of this study is to evaluate whether 89Zr-Df-crefmirlimab (other names 89Zr-crefmirlimab berdoxam and 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.
Recruiting
18+ years
Male or Female
NCT04606316

Surgical Nivolumab And Ipilimumab For Recurrent GBM

Northern America
  • Dana-Farber Cancer Institute
This research trial is studying the safety and effectiveness of nivolumab in combination with ipilimumab and surgery when used in the treatment of recurrent glioblastoma. The names of the study drugs involved in this study are: Nivolumab Ipilimumab Placebo (IV solution with no medicine) 89Zr-Df-IAB22M2C (optional sub-study)
Recruiting
18+ years
Male or Female
NCT03610061

A Trial of Radiotherapy and Durvalumab in DLBCL and FL (RaDD)

Australia
  • Princess Alexandra Hospital
  • Monash Health
  • Austin Health
The primary objective for this study is to determine the safety profile of radiotherapy and durvalumab, a PD-L1 inhibitor. Primary endpoint: Toxicity, drug pharmacokinetics (PK), maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of simultaneous radiotherapy plus durvalumab in patients with relapsed or refractory DLBCL or FL. Secondary endpoints: ORR Progression-free survival Overall survival Exploratory endpoints include description of biological effects of combination radiotherapy plus durvalumab (Imaging results, immune function, PK and PD-see 'research methodologies') and in the PET-Sub-Study, biodistribution of 89Zr Durvalumab and 89Zr-IAB22M2C.
Recruiting
18+ years
Male or Female

An Open-label, multi-center, phase 1B Imaging sub-study of Glofitamab (plus a single Pre-treatment dose of Obinutuzumab) using 89ZR-DF-IAB22M2C as CD8 Tracer in adult patients with relapsed/refractory B-cell Non-Hodgkin's Lymphoma

Belgium
  • UZ Gent
Denmark
  • Rigshospitalet; Fase 1 Enhed
Italy
  • ASST PAPA GIOVANNI XXIII
Spain
  • Hospital Universitari Vall d'Hebron
UK
  • University College London Hospitals NHS Foundation Trust
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
Not Yet Recruiting
50+ years
Male or Female
NCT04874818

CD8+ T-cell PET/CT Imaging in COVID-19 Patients (Tangelo)

Netherlands
  • Radboud University Medical Center
A subset of patients diagnosed with severe acute respiratory syndrome (SARS)-CoV2 infection present with lymphopenia. The degree of lymphopenia, and in particular reduced cluster of differentiation (CD)8+ T-cell numbers, is correlated with clinical deterioration and intensive care unit (ICU) admission. The underlying reasons for lymphopenia in coronavirus disease (COVID)-19 is currently unclear, We aim to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV2 presenting with lymphopenia or with normal lymphocyte counts, using Zirconium-89 ([89Zr])Df-IAB22M2C positron emission tomography (PET) imaging.
Not Yet Recruiting
18+ years
Male or Female
NCT04826393

ASP8374 + Cemiplimab in Recurrent Glioma

Northern America
  • Brigham and Women's Hospital
This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma. The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemiplimab and will be used as the recommended dose of ASP8374 in combination with cemiplimab for the second portion of the study. The second portion of the study will be to compare the effect of having ASP8374 in combination with cemiplimab prior to surgery. The names of the study drugs involved in this study are: ASP8374; Cemiplimab; 89Zr-Df-IAB22M2C (Administered as part of scan procedure)
Completed
18+ years
Male or Female
NCT03107663

⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma

Northern America
  • Memorial Sloan Kettering Cancer Center
  • University of Pennsylvania
  • Honor Health and Imaging Endpoints
To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to determine imaging parameters for optimal lymphoid and tumor visualization.
Recruiting
18+ years
Male or Female
NCT03802123

⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors

Northern America
  • University of Alabama-Birmingham Hospital
  • CARTI Cancer Center
  • City of Hope National Medical Center
  • Keck Hospital of USC
  • LAC + USC Medical Center
  • USC/Norris Comprehensive Cancer Center
  • Hoag Memorial Hospital Presbyterian
  • John Wayne Cancer Institute at Providence Saint John's Health Center
  • University of Iowa Hospitals and Clinics
  • Dana-Farber Cancer Institute
  • Karmanos Cancer Institute
  • Washington University School of Medicine
  • Memorial Sloan Kettering Cancer Center
  • Oregon Health & Science University
  • University of Pennsylvania
Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients with Advanced or Metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck Selected to Receive Standard-of-Care Immunotherapy as Single Agent or in Combination. This study will evaluate the safety of repeat doses of ⁸⁹Zr-Df-IAB22M2C, assess and quantify any detectable changes in ⁸⁹Zr-Df-IAB22M2C uptake from Baseline to post-Treatment, establish the relationship of ⁸⁹Zr-Df-IAB22M2C uptake in tumors with CD8+ TIL density, biodistribution, evaluate the variance in participants' gene expression pre- and post-Treatment, evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with clinical response by RECIST 1.1/iRECIST and evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with immune infiltrates and other molecular biomarkers (CD4, CD8, PD-1 and PD-L1) expression by IHC.