Actively Recruiting
Local Manufacture of CAR T-Cell Products for Treating B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia: A Phase 2a Feasibility Study
Led by John Lister · Updated on 2025-01-13
30
Participants Needed
1
Research Sites
16 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 CAR T-cell products for patients with B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia who have limited treatment options. The study aims to demonstrate that these locally produced CAR T-cells can be reliably created and safely administered, following a Phase 2a trial design. The trial focuses on patients with specific CD19-positive lymphomas or leukemia who have failed previous therapies or have no curative options available. Participants undergo a sequence of procedures including eligibility screening, informed consent, and collection of their T-cells through apheresis. These cells are processed and modified using the CliniMACS Prodigy device to create CAR T-cells targeting CD19. Patients then receive lymphodepleting chemotherapy followed by an intravenous infusion of their own CAR T-cells on day 0. The first three patients will be closely monitored in the hospital for two weeks to assess treatment safety, with ongoing clinical follow-up and laboratory monitoring extending up to 15 years. Throughout the study, patients will have regular assessments including flow cytometry testing to monitor CAR T-cell levels at day 30 and 100, clinical evaluations monthly to day 100, and then less frequent follow-ups up to 15 years or until death. Safety evaluations focus on detecting toxicities such as cytokine release syndrome and neurological effects. Data from all participants will be reported anonymously to a national registry. The care provided aligns with standard practices used for commercially available CAR T-cell products, with additional study-specific monitoring for research purposes.
CONDITIONS
Brief 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
- Diagnosis of CD19-positive B-cell lymphoma or B-Cell Acute Lymphoblastic Leukemia with no curative treatment option and limited prognosis
- 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
- Pathological evidence of CD19 expression on lymphoma or ALL cells
- Patients with measurable or assessable disease (not in complete remission) for lymphoma
- B-ALL patients must have measurable disease on two separate occasions at least 2 weeks apart
- Relapse more than 100 days after hematopoietic stem cell transplant with no active graft versus host disease
- Female participants of childbearing potential must have negative pregnancy test and use contraception during and one year after treatment
- Male participants must use birth control from enrollment through 6 months after preparative treatment
- Cardiac ejection fraction 0.45 or higher
- No supplemental oxygen needed and normal lung function
- Karnofsky performance score 70 or higher
- Expected survival greater than 12 weeks
- Ability to understand and consent to the study
- Consent to anonymous data reporting to national registry
You will not qualify if you...
- Active HIV infection with viral replication (patients with undetectable viral load on treatment may be eligible)
- Active hepatitis B or C infection with viral replication
- Active central nervous system leukemia or lymphoma untreated
- Active bacterial, fungal, or viral infection
- Concurrent second cancer requiring active treatment (stable breast or prostate cancer on hormonal therapy may be allowed)
- Recent heart attack within 6 months or uncontrolled heart conditions
- Use of investigational drugs within 30 days before cell collection
- Anti-cancer therapy within 4 weeks before cell collection
- Radiation therapy within 14 days before cell collection
- Checkpoint inhibitor or high-dose corticosteroid use within 4 weeks before cell collection
- Immunosuppressive therapy that cannot be stopped 4 weeks prior to cell collection
- Significant laboratory abnormalities indicating blood, liver, or kidney disease
- Pregnant or breastfeeding women
- Conditions impairing ability to consent or comply, including vulnerable populations such as homeless or prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration until CAR T-cell infusion on day 0
Participants undergo cell collection by apheresis followed by CAR T-cell manufacturing and lymphodepleting chemotherapy before CAR T-cell infusion.
1 to 2 visits for cell collection and preparative chemotherapy
Duration - Day 0 to day +14
Participants receive CAR T-cell infusion and are monitored intensively in hospital for toxicity including CRS and ICANS.
Daily inpatient visits for up to 14 days
Duration - Day +15 to day +30
Participants continue monitoring in the Medical Short Stay Unit or similar setting until day +30, with possible reduced visit frequency based on clinical condition.
Daily or thrice weekly visits until day 30
Duration - Day +31 to day +100
Participants are seen monthly for clinical examination and response assessment until day +100, including CAR T-cell monitoring by flow cytometry.
Monthly visits up to day 100
Duration - From day +101 to up to 15 years
Participants continue clinical follow-up every 3 months to 2 years, then every 6 months up to 5 years, and yearly up to 15 years or until death.
Every 3 months to 2 years, then every 6 months up to 5 years, then yearly visits
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
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