Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC

Status Recruiting

Clinical Trial Summary

The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration. How many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future. There are two parts to this study. In part 1, blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy. The data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested. Eligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06096038
Study type	Interventional
Source	UNC Lineberger Comprehensive Cancer Center
Contact	Catherine Cheng
Phone	+1 919-445-4208
Email	UNCImmunotherapy@med.unc.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	April 5, 2024
Completion date	August 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05808920` - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed	`NCT02526017` - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers	Phase 1
Recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT03997643` - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial	Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04700475` - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.	N/A
Withdrawn	`NCT04058145` - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma	Phase 2
Completed	`NCT02572869` - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting	`NCT04474470` - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer	Phase 1/Phase 2
Withdrawn	`NCT05073809` - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Active, not recruiting	`NCT03651570` - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study	N/A
Recruiting	`NCT04930432` - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06016699` - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated	`NCT03843554` - Commensal Oral Microbiota in Head and Neck Cancer	N/A
Recruiting	`NCT05915572` - Mulligan Technique on Shoulder Dysfunction	N/A
Recruiting	`NCT05897983` - Tens and Rocabado Exercises on TMJ Dysfunction	N/A
Withdrawn	`NCT05263648` - Virtual Reality Software to Reduce Stress in Cancer Patients	N/A
Withdrawn	`NCT03238638` - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy	Phase 2
Active, not recruiting	`NCT03688646` - Efficacy of ONS Supplementation in HNC Outpatient Under Treatment	N/A