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 range18 Years

SexALL

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.
✕. Active acute or chronic GVHD requiring systemic therapy.
✕. Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications.
✕. RETIRED WITH PROTOCOL AMENDMENT V7
✕. Receipt of prior huCART19 therapy.
✕. CNS disease as defined by disease-cohort as follows:

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 range18 Years

SexALL

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.
✕. Active acute or chronic GVHD requiring systemic therapy.
✕. Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications.
✕. RETIRED WITH PROTOCOL AMENDMENT V7
✕. Receipt of prior huCART19 therapy.
✕. CNS disease as defined by disease-cohort as follows:

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