Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

NCT05108805 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: VICC CTT 2109
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria

Conditions

Large B-cell Lymphoma; Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (5)

• Number of Participants That Received YESCARTA

  The number of participants that received YESCARTA as outpatient therapy

  Approximately 6 weeks

• Participants That Required Hospitalization at 72 Hours Post Infusion

  Number of subjects that were admitted to hospital at 72 hours post infusion

  at 72 hours

• Participants That Required Hospitalization at 7 Days Post Infusion

  Number of subjects that were admitted to the hospital at 7 days post infusion

  at 7 days

• Participants That Required Hospitalization at 14 Days Post Infusion

  Number of subjects that were admitted to the hospital at 14 days post infusion

  at 14 days

• Participants That Required Hospitalization at 30 Days Post Infusion

  Number of subjects that were admitted to hospital at 30 days post infusion

  at 30 days

Secondary Outcomes (5)

• Count of Risk Factors That Preclude Out-patient Administration of YESCARTA

  Approximately 30 days

• Participants That Experienced Cytokine Release Syndrome Events

  Approximately 30 days

• Participants That Experienced Immune Effector Cell-associated Neurotoxicity Syndrome Events

  Approximately 30 days

• Incidence of Steroid Administration During YESCARTA

  Approximately 30 days

• Cost Per Patient of Administering YESCARTA in the Out-patient Setting

  Approximately 30 days

Study Arms (1)

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

EXPERIMENTAL

Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.

Procedure: Telemedicine Visit; Procedure: Vital sign measurements; Procedure: Out-Patient Clinic Visit; Procedure: Blood pressure and pulse oximeter; Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

Telemedicine Visit PROCEDURE

A remote telemedicine visit with audio and video, using the internet with a nurse practitioner (NP) located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, heart rate (HR), respiration rate (RR), SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

Vital sign measurements PROCEDURE

Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

Out-Patient Clinic Visit PROCEDURE

Physical exam and review of all available data

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

Blood pressure and pulse oximeter PROCEDURE

Participant and their family take their blood pressure and pulse oximeter

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

Axicabtagene Ciloleucel BIOLOGICAL

Axicabtagene Ciloleuce given by IV

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

Cyclophosphamide DRUG

Given IV

Also known as: Cyclophosphamide 500 mg/m^2/day, Cytoxan®

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

Fludarabine DRUG

Given IV

Also known as: Fludarabine 30 mg/m^2/day, Fludara®

YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and above
• Histologically proven large B cell lymphoma or transformed follicular lymphoma to DLBCL in relapse/refractory after two lines of therapies which included an anthracycline and CD20-targeted therapy.
• Chemotherapy refractory disease evidenced by lack of adequate response to first line therapy. This consists of either progressive disease as best response to first line therapy or stable disease as best response after 4 cycles of appropriate chemotherapy
• Refractory after autologous stem cell transplant (ASCT) at any time point
• And
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate hematologic, hepatic, renal and cardiac function evidenced by:
• absolute neutrophil count (ANC) ≥1000/µL
• Platelet ≥ 75,000/ µL
• T-bilirubin ≤ 1.5 mg/dL
• Normal serum creatinine or creatinine clearance ≥ 60 mL/min/1.73 m2
• Cardiac ejection fraction ≥ 50%
• Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 5 times upper limit of normal (ULN).
• At least 1 measurable lesion
• Baseline oxygen saturation ≥92% on room air.

You may not qualify if:

• History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.
• Known CD19 negative tumor.
• History of Richter's transformation of chronic lymphocytic leukemia (CLL).
• Autologous stem cell transplant with therapeutic intent within 6 weeks of planned YESCARTA infusion.
• History of allogeneic stem cell transplantation.
• Prior CAR therapy or other genetically modified T-cell therapy.
• History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
• Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor.
• History of human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or hepatitis C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines or applicable country guidelines.
• Presence of any in-dwelling line or drain (e.g., percutaneous nephrostomy tube, in-dwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted.
• Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases. Patients with treated secondary CNS involvement of lymphoma are allowed.
• History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, progressive multifocal leukoencephalopathy, or any autoimmune disease with CNS involvement if it impairs ability to complete an effective and reliable neurological assessment.
• Subjects with cardiac atrial or cardiac ventricular lymphoma involvement.
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment.
• Requirement for urgent therapy due to tumor mass effects (e.g., blood vessel compression, bowel obstruction, or transmural gastric involvement).

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• Kite, A Gilead Company: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Blood Pressure; axicabtagene ciloleucel; Cyclophosphamide; fludarabine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Olalekan Oluwole
• Organization: Vanderbilt University Medical Center

olalekan.oluwole@vumc.org

(615) 936-8422

Study Officials

• Olalekan Oluwole, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 5, 2021
• Study Start: December 2, 2021
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)