Actively Recruiting
TmCD19-IL18 in CD19+ Cancers
Led by University of Pennsylvania · Updated on 2025-09-05
24
Participants Needed
1
Research Sites
933 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
K
Kite, A Gilead Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase I, open-label dose finding study to assess the safety and feasibility, pharmacokinetics, and preliminary efficacy of TmCD19-IL18 CAR T cells in patients with CD19+ cancers. This study will take place in two parts: a Dose-Finding Phase to determine the maximum tolerate dose (MTD), followed by a Dose Expansion Phase. In the Dose-Finding Phase, dose levels will be evaluated using a 3+3 dose escalation design to determine the MTD. Cumulative safety experience and manufacturing feasibility data from the Dose-Finding Phase will then be used to identify the dose level that can be progressed into the Dose Expansion Phase.
CONDITIONS
Official Title
TmCD19-IL18 in CD19+ Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Documentation of CD19 expression on malignant cells by flow cytometry or immunohistochemistry from a certified laboratory
- For Non-Hodgkin Lymphoma (NHL) patients, CD19 expression confirmed within 6 months without intervening CD19 therapy, or older results if no accessible tumor and no intervening therapy
- Patients with relapsed disease after prior allogeneic stem cell transplant (SCT) must have no active graft-versus-host disease (GVHD), require no immunosuppression, and be more than 6 months from transplant
- Adequate organ function including creatinine clearance over 35 mL/min, liver enzymes (ALT/AST) no more than three times the upper limit, bilirubin no more than 2.0 mg/dl (3.0 mg/dl if Gilbert's syndrome), lung function with mild or no dyspnea and oxygen saturation above 92%, and left ventricle ejection fraction of at least 40%
- Evidence of active disease within 12 weeks before eligibility confirmation
- Male or female age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Disease-specific criteria for NHL including various lymphoma subtypes with relapsed or refractory status after prior therapies or stem cell transplants as detailed in the protocol
You will not qualify if you...
- Active hepatitis B, active hepatitis C, or other uncontrolled infections
- Severe cardiovascular disability classified as Class III or IV by the New York Heart Association
- Unstable arrhythmias within two weeks before eligibility confirmation
- Active acute or chronic graft-versus-host disease requiring systemic therapy
- Dependence on systemic steroids or immunosuppressants
- Previous treatment with huCART19-IL18 therapy
- Active central nervous system (CNS) disease as defined by cohort criteria; past CNS involvement that was successfully treated is allowed
- Pregnant or nursing women; participants of reproductive potential must use acceptable birth control
- Known history or diagnosis of optic neuritis or other inflammatory diseases affecting the central nervous system unrelated to cancer or prior treatment
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to 10 mg or more of prednisone; autoimmune neurological diseases such as multiple sclerosis are excluded
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Abramson Cancer Center Clinical Trial Services
CONTACT
J
Jakub Svoboda, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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