Actively Recruiting
Local Production of CAR T-Cell Therapy for Treating B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia A Feasibility Study to Assess Manufacturing and Safety
Led by John Lister · Updated on 2025-01-13
30
Participants Needed
1
Research Sites
815 weeks
Total Duration
On this page
Sponsors
J
John Lister
Lead Sponsor
L
Lentigen Technology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of locally manufacturing Chimeric Antigen Receptor (CAR) T-cell products to treat patients with B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia who have limited treatment options and a poor prognosis. This phase 2a study aims to demonstrate that CAR T-cells targeting the CD19 antigen can be reliably produced and safely administered using a local automated cell processing system. The treatment process includes eligibility screening, informed consent, collection of T-cells through apheresis, local CAR T-cell manufacturing using the CliniMACS Prodigy device with a lentiviral vector, lymphodepleting chemotherapy, and intravenous infusion of the CAR T-cells on day 0. The first three patients will be hospitalized for 14 days post-infusion for close monitoring. Subsequent patients may have reduced hospitalization based on initial safety results, followed by outpatient monitoring. CAR T-cell presence is checked by flow cytometry on days 30 and 100. Disease response is assessed at day 30 and monitored regularly up to 15 years. Participants will undergo frequent safety and response evaluations including clinical exams, laboratory tests, and CAR T-cell detection. Monitoring for toxicities such as CRS and ICANS occurs intensively early on, with longer-term follow-up extending to 15 years or until death. Data will be anonymously reported to a transplant registry. The study follows standard clinical care practices, with the only experimental procedures being CAR T-cell manufacturing and a blood test to detect CAR T-cells.
CONDITIONS
Official Title
Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 80 years
- Diagnosed with CD19-positive B-cell lymphoma or B-Cell Acute Lymphoblastic Leukemia with no curative treatment options and limited prognosis (less than 2-year survival)
- Peripheral blood CD3 count greater than 200/µL by flow cytometry
- Failed at least two lines of therapy for lymphoma or one line for B-ALL, including conventional chemotherapy for at least two cycles
- Pathological or clinical evidence of transformed indolent lymphoma treated with at least one line of therapy for transformed disease
- Demonstrated CD19 expression on lymphoma or ALL cells
- Unable to receive commercially available CD19-CAR T-cell therapy
- Lymphoma patients must have measurable or assessable disease; B-ALL patients must have detectable disease on two occasions at least 2 weeks apart
- Subjects relapsing more than 100 days after autologous or allogeneic stem cell transplant; allogeneic transplant recipients must be off immunosuppression for 4 weeks and free of graft versus host disease
- Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception for at least one year post-infusion
- Male participants must agree to use birth control from enrollment through 6 months post-treatment
- Cardiac ejection fraction at least 0.45 by MUGA or echocardiography
- No need for supplemental oxygen and no resting shortness of breath; lung function tests at least 65% of predicted
- Karnofsky performance score of 70 or higher
- Expected survival greater than 12 weeks
- Able to understand risks and consent independently
- Consent to anonymous data reporting to CIBMTR
You will not qualify if you...
- Active HIV infection with viral replication; patients on antiretroviral therapy with undetectable viral load may be eligible
- Active hepatitis B or C infection with viral replication
- Active untreated central nervous system leukemia or lymphoma; treated CNS disease may be eligible if inactive with clear cerebrospinal fluid and stable brain imaging
- Active bacterial, fungal, or viral infection
- Concurrent second cancer requiring active therapy, except stable breast or prostate cancer on hormonal treatment
- Recent myocardial infarction within 6 months, symptomatic heart disease, or uncontrolled arrhythmia
- Use of investigational drugs within 30 days before cell collection
- Anti-cancer therapy within 4 weeks before cell collection including anti-CD19 therapies, monoclonal antibodies, bispecific T-cell engagers, and certain targeted therapies
- Radiation therapy within 14 days before cell collection or with toxicity above grade 2
- Checkpoint inhibitor therapy within 4 weeks before cell collection
- Corticosteroid therapy at high doses within 4 weeks before cell collection
- Immunosuppressive therapy that cannot be stopped 4 weeks before cell collection
- Significant abnormal blood tests indicating severe blood, liver, or kidney problems
- Pregnant or breastfeeding women
- Expected non-compliance with study procedures
- Vulnerable populations unable to provide informed consent or comply with study schedules, including homeless, developmentally disabled, or prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AHN Cancer Institute - West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
J
John Lister, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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