Active — Not RecruitingPhase 1

huCART19-IL18 in CD19+ Cancers

United States72 participantsStarted 2021-05-06

Plain-language summary

The purpose of this study is to evaluate the safety and feasibility of huCART19-IL18 cells in patients with relapsed or refractory CD19+ cancers.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent form
. Documentation of CD19 expression on malignant cells by flow cytometry/IHC from a CLIA certified laboratory
. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:
. Adequate organ function defined as:
. Evidence of active disease within 12 weeks of physician-investigator confirmation of eligibility. .
. Male or female age ≥ 18 years.
. ECOG Performance Status that is either 0 or 1.
. Subjects of reproductive potential must agree to use acceptable birth control methods.

Exclusion criteria

. Active hepatitis B, active hepatitis C, or other active, uncontrolled infection.
. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
. Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

Timeframe: Up to 15 years post-huCART19-IL18 infusion

Occurrence of dose-limiting toxicities (DLTs)

Timeframe: 28 days post-huCART19-IL18 infusion

Determination of Maximum Tolerated Dose (MTD)

Timeframe: 28 days post-huCART19-IL18 infusion

Determination of a recommended dose for expansion (RDE)

Timeframe: 3 months post-huCART19-IL18 infusion

Proportion of manufactured products that meet the product release criteria

Timeframe: 3 months

Proportion of manufactured products that meet the assigned dose

Timeframe: 3 months

Trial details

NCT IDNCT04684563

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2036-05

View on ClinicalTrials.gov More Chronic Lymphocytic Leukemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent form
. Documentation of CD19 expression on malignant cells by flow cytometry/IHC from a CLIA certified laboratory
. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:
. Adequate organ function defined as:
. Evidence of active disease within 12 weeks of physician-investigator confirmation of eligibility. .
. Male or female age ≥ 18 years.
. ECOG Performance Status that is either 0 or 1.
. Subjects of reproductive potential must agree to use acceptable birth control methods.

Exclusion criteria

. Active hepatitis B, active hepatitis C, or other active, uncontrolled infection.
. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
. Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.

What they're measuring

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

Timeframe: Up to 15 years post-huCART19-IL18 infusion

Occurrence of dose-limiting toxicities (DLTs)

Timeframe: 28 days post-huCART19-IL18 infusion

Determination of Maximum Tolerated Dose (MTD)

Timeframe: 28 days post-huCART19-IL18 infusion

Determination of a recommended dose for expansion (RDE)

Timeframe: 3 months post-huCART19-IL18 infusion

Proportion of manufactured products that meet the product release criteria

Timeframe: 3 months

Proportion of manufactured products that meet the assigned dose

Timeframe: 3 months