Actively Recruiting
Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia
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
This trial aims to demonstrate the feasibility of this approach to reliably generate product and to safely administer the product to patients who have B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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