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CAR T-cell Therapy
CAR T-cell Therapy for Blood Cancer
Phase 1
Recruiting
Led By Jakub Svoboda, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
--- Patients must have either failed or be ineligible for standard of care Tecartus™ (brexucabtagene autoleucel) or other investigational CAR T cell product; and
--- Relapsed/refractory disease after allogeneic SCT.
Must not have
Active acute or chronic GVHD requiring systemic therapy.
Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Summary
This trial aims to find the safest dose of specially modified immune cells for patients with certain types of cancers that have a specific marker. These cancers include Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Acute Lymphoblastic Leukemia. The modified cells are designed to seek out and destroy cancer cells with this marker.
Who is the study for?
Adults with CD19+ cancers like various leukemias and lymphomas, who have active disease despite previous treatments. They must be over 18, in fairly good health (ECOG 0 or 1), with decent organ function and no severe heart issues. Active infections or autoimmune diseases are deal-breakers, as is recent use of certain immune drugs.
What is being tested?
The trial is testing the safety of a new cell therapy called huCART19-IL18 for blood cancers that have a marker called CD19. The goal is to find the highest dose people can take without serious side effects.
What are the potential side effects?
Potential side effects aren't specified here but generally may include flu-like symptoms, fatigue, allergic reactions to the infusion, and possibly more serious immune system-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot use or have not responded to standard CAR T cell therapy.
Select...
My condition worsened or didn't improve after a stem cell transplant.
Select...
I don't have active graft-versus-host disease and don't need immunosuppressants.
Select...
My chronic lymphocytic leukemia has recently relapsed.
Select...
My condition did not improve after initial treatment or I've had at least one treatment.
Select...
My CLL has transformed into a more aggressive form.
Select...
I don't have active graft-versus-host disease and don't need immunosuppressants.
Select...
I am fully active or can carry out light work.
Select...
My condition did not improve after 2 treatments and I can't have stem cell or CAR T cell therapy.
Select...
My condition worsened after 2 treatments, including a BTK inhibitor.
Select...
My condition worsened or didn't improve after a stem cell transplant.
Select...
I have minor or no breathing issues and my oxygen level is above 92% without assistance.
Select...
a. Your creatinine level is less than or equal to 1.6 mg/dl.
b. Your ALT/AST levels are less than or equal to 3 times the upper limit of normal range.
c. Your direct bilirubin level is less than or equal to 2.0 mg/dl, except if you have Gilbert's syndrome, where it can be up to 3.0 mg/dl.
d. You have good lung function with minimal difficulty breathing and pulse oxygen levels above 92% on room air.
e. Your left ventricle ejection fraction (LVEF) is at least 40%, confirmed by ECHO/MUGA.
Select...
My condition did not improve after two different treatments.
Select...
I have been diagnosed with a specific type of aggressive B-cell lymphoma.
Select...
My condition worsened or didn't improve after a stem cell transplant using my own cells.
Select...
My condition worsened or didn't improve after a stem cell transplant.
Select...
My cancer cells test positive for CD19.
Select...
My cancer is active, showing signs in blood, bone marrow, or measurable disease.
Select...
My condition relapsed after a stem cell transplant from a donor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am receiving treatment for ongoing GVHD.
Select...
I am on strong medication for an autoimmune disease, but I don't have MS.
Select...
I do not have active hepatitis B or C, or any uncontrolled infection.
Select...
I have severe heart problems that limit my daily activities.
Select...
I haven't taken immune checkpoint inhibitors in the last 4 months.
Select...
I have previously received huCART19 therapy.
Select...
I rely on steroids or immunosuppressant drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Best Overall Response (BOR)
Characterize low level disease and B cell assessment in response to huCART19-IL18 cells
Event Free Survival (EFS)
+2 moreTrial Design
17Treatment groups
Experimental Treatment
Group I: NHL Dose Level 5 (DL5)Experimental Treatment1 Intervention
3x10\^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group II: NHL Dose Level 4 (DL4)Experimental Treatment1 Intervention
7x10\^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group III: NHL Dose Level 3 (DL3)Experimental Treatment1 Intervention
3x10\^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group IV: NHL Dose Level 2 (DL2)Experimental Treatment1 Intervention
7x10\^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group V: NHL Dose Level 1b (DL1b)Experimental Treatment1 Intervention
3x10\^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group VI: NHL Dose Level 1a (DL1a)Experimental Treatment1 Intervention
3x10\^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push
Group VII: NHL Dose Level -1 (DL-1)Experimental Treatment1 Intervention
7x10\^5 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 1a.
Group VIII: CLL Dose Level 5 (DL5)Experimental Treatment1 Intervention
3x10\^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group IX: CLL Dose Level 4 (DL4)Experimental Treatment1 Intervention
7x10\^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group X: CLL Dose Level 3 (DL3)Experimental Treatment1 Intervention
3x10\^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group XI: CLL Dose Level 2 (DL2)Experimental Treatment1 Intervention
7x10\^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group XII: CLL Dose Level 1b (DL1b)Experimental Treatment1 Intervention
3x10\^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 2.
Group XIII: ALL Dose Level 5 (DL5)Experimental Treatment1 Intervention
3x10\^8 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group XIV: ALL Dose Level 4 (DL4)Experimental Treatment1 Intervention
7x10\^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group XV: ALL Dose Level 3 (DL3)Experimental Treatment1 Intervention
3x10\^7 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group XVI: ALL Dose Level 2 (DL2)Experimental Treatment1 Intervention
7x10\^6 huCART19-IL18 cells following lymphodepleting chemotherapy administered as a single intravenous (IV) infusion or slow IV push
Group XVII: ALL Dose Level 1b (DL1b)Experimental Treatment1 Intervention
3x10\^6 huCART19-IL18 cells administered as a single intravenous (IV) infusion or slow IV push; This dose level will only be explored if at least one DLT is observed at Dose Level 2.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells.
Immunotherapy, such as monoclonal antibodies (e.g., rituximab), targets specific proteins on cancer cells to mark them for destruction by the immune system. Targeted therapies, like kinase inhibitors, block specific molecules involved in cancer cell growth and survival.
CAR T-cell therapy, particularly those targeting CD19, involves modifying a patient's T cells to express a receptor that recognizes and binds to CD19 on B cells, leading to the destruction of these cancerous cells. The addition of IL-18 in huCART19-IL18 cells aims to enhance the immune response, potentially improving the efficacy of the treatment.
These mechanisms are crucial for NHL patients as they offer targeted approaches to eliminate cancer cells while sparing normal cells, potentially leading to better outcomes and fewer side effects.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,063 Previous Clinical Trials
42,711,840 Total Patients Enrolled
Jakub Svoboda, MDPrincipal InvestigatorUniversity of Pennsylvania
6 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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