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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing how safe it is to give people higher doses of a new cancer treatment.

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.Check my eligibility
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.See study design
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 below
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I cannot use or have not responded to standard CAR T cell therapy.
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My condition worsened or didn't improve after a stem cell transplant.
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I don't have active graft-versus-host disease and don't need immunosuppressants.
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My NHL was confirmed to be CD19 positive within the last 6 months, and I haven't had CD19 targeted therapy since.
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My chronic lymphocytic leukemia has recently relapsed.
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My condition did not improve after initial treatment or I've had at least one treatment.
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My CLL has transformed into a more aggressive form.
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I don't have active graft-versus-host disease and don't need immunosuppressants.
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I am fully active or can carry out light work.
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I am fully active or can carry out light work.
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My condition did not improve after 2 treatments and I can't have stem cell or CAR T cell therapy.
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My condition worsened after 2 treatments, including a BTK inhibitor.
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It has been over 6 months since my transplant.
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My condition worsened or didn't improve after a stem cell transplant.
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I have minor or no breathing issues and my oxygen level is above 92% without assistance.
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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.
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My condition did not improve after two different treatments.
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My cancer cells test positive for CD19.
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I have been diagnosed with a specific type of aggressive B-cell lymphoma.
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My cancer is active, as shown by tests on my blood, bone marrow, or through specific measurements.
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My condition worsened or didn't improve after a stem cell transplant using my own cells.
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My condition worsened or didn't improve after a stem cell transplant.
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My cancer cells test positive for CD19.
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My cancer is active, showing signs in blood, bone marrow, or measurable disease.
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I am 18 years old or older.
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My condition relapsed after a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.
Secondary outcome measures
Best Overall Response (BOR)
Characterize low level disease and B cell assessment in response to huCART19-IL18 cells
Determination of Maximum Tolerated Dose (MTD)
+8 more

Trial 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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,993 Previous Clinical Trials
42,875,491 Total Patients Enrolled
Jakub Svoboda, MDPrincipal InvestigatorUniversity of Pennsylvania
5 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

huCART19-IL18 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684563 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this research endeavor?

"Confirmed. According to clinicaltrials.gov, this medical research project is actively recruiting participants, having first been posted on May 6th 2021 and most recently edited on October 31st 2022. The study seeks 30 enrollees at a single site of operation."

Answered by AI

Is there a call for volunteers at this time to participate in the clinical trial?

"Affirmative. Records on clinicaltrials.gov demonstrate that this healthcare trial, which was first posted on May 6th 2021, is still in the process of recruiting patients. Approximately 30 individuals are required to be recruited from 1 site."

Answered by AI

Has the FDA authorized huCART19-IL18 for medicinal use?

"The safety of huCART19-IL18 was conservatively estimated at a score of 1 due to the nature of Phase 1 trials, which only have limited data supporting efficacy and safety."

Answered by AI
~48 spots leftby May 2036