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huCART19-IL18 in CD19+ Cancers | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

huCART19-IL18 in CD19+ Cancers

Phase I Trial of huCART19-IL18 Cells in Patients With Relapsed or Refractory CD19+ Cancers

NCT04684563•University of Pennsylvania

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.

Detailed Description

This is a Phase I study to assess the safety, tolerability, manufacturing feasibility, pharmacokinetics, and preliminary efficacy of huCART19-IL18 cells in patients with CD19+ cancers. The study will take place in two parts: an initial Dose-Finding Phase and an Expansion Phase. In the dose-finding phase, the maximum tolerated dose will be determined using a Bayesian Optimal Interval (BOIN) design within each of the following disease-specific cohorts: * Cohort A: Non-Hodgkin Lymphoma (Active, Not Recruiting) * Cohort B: Chronic Lymphocytic Leukemia (Active, Not Recruiting) * Cohort C: Acute Lymphoblastic Leukemia (Active, Not Recruiting) * Cohort D (Expansion Phase): Non Hodgkin Lymphoma and Acute Lymphoblastic Leukemia (Active, Not Recruiting) will evaluate changes to cell activation method in the huCART19-IL18 manufacturing process using the recommended dose for expansion (RDE) arising out of the dose-finding phase.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent form
•2. Documentation of CD19 expression on malignant cells by flow cytometry/IHC from a CLIA certified laboratory
•NHL Patients: Within 6 months of physician-investigator confirmation of eligibility as long as there has been no intervening CD19 directed therapy since expression confirmed. Results outside of this window may be used, if there is no accessible tumor site and the subject did not receive intervening CD19 directed therapy since CD19 expression was confirmed.
•CLL and ALL Patients: At time of most recent relapse. If the subject has subsequently received CD19-directed therapy since this result was obtained, repeating testing must be performed to determine eligibility.
•3. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:
•a. Have no active GVHD and require no immunosuppression b. Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility
•4. Adequate organ function defined as:
•a. Creatinine ≤ 1.6 mg/dl b. ALT/AST ≤ 3x upper limit of normal range c. Direct bilirubin ≤ 2.0 mg/dl, unless the subject has Gilbert's syndrome (≤3.0 mg/dl) d. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air e. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
•5. Evidence of active disease within 12 weeks of physician-investigator confirmation of eligibility. .
•6. Male or female age ≥ 18 years.
+31 more criteria

Exclusion Criteria

•1. Active hepatitis B, active hepatitis C, or other active, uncontrolled infection.
•2. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
•3. Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
•4. Active acute or chronic GVHD requiring systemic therapy.
•5. Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications.
•6. RETIRED WITH PROTOCOL AMENDMENT V7
•7. Receipt of prior huCART19 therapy.
•8. CNS disease as defined by disease-cohort as follows:
•1. NHL/CLL Patients: Active CNS disease. Note: Patients with a history of CNS involvement that was successfully treated are eligible. A CNS evaluation is only required for eligibility if a subject is experiencing signs/symptoms of CNS involvement.
•2. ALL Patients: CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
+3 more criteria

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

May 6, 2021

Primary Completion Date

May 1, 2036

Completion Date

May 1, 2036

Last Updated

November 10, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Lymphocytic LeukemiaNon-hodgkin LymphomaAcute Lymphoblastic Leukemia

Interventions

huCART19-IL18

BIOLOGICAL

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

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T-cell Acute Lymphoblastic LeukemiaRecruiting

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RECRUITINGPHASE1

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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huCART19-IL18 in CD19+ Cancers

Inclusion Criteria

Exclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation