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RECRUITING Phase 1

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT03331198 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Interventions

  • BIOLOGICAL JCAR017 (lisocabtagene maraleucel)
  • BIOLOGICAL JCAR017 (lisocabtagene maraleucel) + ibrutinib
  • BIOLOGICAL JCAR017 (lisocabtagene maraleucel) + venetoclax

Study Locations (20)

California

  • City of Hope — Duarte
  • City Of Hope — Duarte
  • UC San Diego Moores Cancer Center — La Jolla
  • University Of California San Diego Moores Cancer Center — La Jolla
  • Local Institution - 0059 — Los Angeles
  • University of California, Los Angeles — Los Angeles
  • Local Institution - 0010 — San Francisco
  • University of California, San Francisco — San Francisco

Alabama

  • University of Alabama at Birmingham — Birmingham
  • University of Alabama Birmingham — Birmingham

Arizona

  • Banner MD Anderson Cancer Center — Gilbert
  • Banner MD Anderson Cancer Center — Gilbert

District of Columbia

  • Georgetown University Medical Center — Washington D.C.
  • Local Institution - 0085 — Washington D.C.

Florida

  • Mayo Clinic - Jacksonville — Jacksonville
  • Mayo Clinic — Jacksonville

Georgia

  • Local Institution - 0104 — Atlanta
  • Local Institution - 0019 — Atlanta

Colorado

  • Colorado Blood Cancer Institute — Denver

Delaware

  • Local Institution - 0110 — Newark

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2017-11-27
Est. Completion 2027-11-26
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03331198

The ClinicalTrials.gov registry entry for NCT03331198 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Juno Therapeutics, a Subsidiary of Celgene, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Leukemia, Lymphocytic, Chronic, B-Cell appearing as the primary indexed condition, and to 3 interventions — of which JCAR017 (lisocabtagene maraleucel) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03331198 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03331198 about?

NCT03331198 is a clinical study titled "Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)". This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or S...

What is the current status of trial NCT03331198?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2017-11-27. Estimated completion is 2027-11-26.

What conditions does trial NCT03331198 study?

This clinical trial studies the following conditions: Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Small Lymphocytic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03331198?

The interventions under investigation include: JCAR017 (lisocabtagene maraleucel) (BIOLOGICAL), JCAR017 (lisocabtagene maraleucel) + ibrutinib (BIOLOGICAL), JCAR017 (lisocabtagene maraleucel) + venetoclax (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03331198?

This trial is sponsored by Juno Therapeutics, a Subsidiary of Celgene, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03331198 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial