TerminatedPhase 1/2

A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)

Stopped: Absence of significant therapeutic benefit over existing therapies

United States21 participantsStarted 2018-10-17

Plain-language summary

This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL. Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, \[DLBCL, BL, or PMBCL\]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.

Who can participate

Age range25 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

✓. Phase 1: Subject \< 18 years of age and weighs ≥ 6 kg at the time of signing the informed consent form (ICF)/informed assent form (IAF).
✓. Subject (when applicable, parental/legal representative) must understand and voluntarily provide permission to the ICF/IAF prior to conducting any study-related assessments/procedures.
✓. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
✓. Investigator considers the subject is appropriate for adoptive T cell therapy.
✓. Evidence of CD19 expression via flow cytometry (peripheral blood or bone marrow) or immunohistochemistry (bone marrow biopsy)
✓. Subject has a Karnofsky score of ≥ 50 (subjects ≥ 16 years of age) or a Lansky score ≥ 50 (subjects \< 16 years of age).
✓. Diagnosis of B-cell ALL or B-cell NHL as defined below:
✓. Subjects with Philadelphia chromosome positive ALL are eligible if they are intolerant to or have failed one or more lines of tyrosine-kinase inhibitor (TKI) therapy or if TKI therapy is contraindicated.

Exclusion criteria

What they're measuring

Number of Participants With Treatment Emergent Adverse Events up to 30 Days Post JCAR017 Infusion

Timeframe: From first JCAR017 infusion (Day 1) to 30 days after JCAR017 infusion

Number of Participants With Dose Limiting Toxicities

Timeframe: From first JCAR017 infusion (Day 1) to 28 days after JCAR017 infusion

Concentration of JCAR017 in Peripheral Blood at Day 28 Post JCAR017 Infusion

Timeframe: At day 28 post JCAR017 infusion

Trial details

NCT IDNCT03743246

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-26

Results submitted2024-07-22

View on ClinicalTrials.gov More Precursor Cell Lymphoblastic Leukemia-Lymphoma trials