Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 1

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

NCT03960840 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).

Interventions

  • DRUG Ibrutinib
  • BIOLOGICAL Rapcabtagene autoleucel single agent

Study Locations (20)

Other

  • Novartis Investigative Site — Vienna
  • Novartis Investigative Site — Marseille
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Pierre-Bénite
  • Novartis Investigative Site — Rennes

California

  • University of California LA — Los Angeles
  • Stanford University Medical Center — Stanford

Tennessee

  • Sarah Cannon Research Institute — Nashville
  • Sarah Cannon Research Institute — Nashville

Texas

  • St Davids South Austin Medical Ctr — Austin
  • Uni Of TX MD Anderson Cancer Cntr — Houston

Victoria

  • Novartis Investigative Site — Melbourne
  • Novartis Investigative Site — Melbourne

Florida

  • H Lee Moffitt Cancer Center and Research Institute — Tampa

Illinois

  • Uni of Chi Medi Ctr Hema and Onco — Chicago

Kansas

  • University of Kansas Cancer Center — Westwood

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2019-06-26
Est. Completion 2028-05-31
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

792 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03960840

The ClinicalTrials.gov registry entry for NCT03960840 describes a study currently listed as active not 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 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions — of which Ibrutinib 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: NCT03960840 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Tennessee. 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 NCT03960840 about?

NCT03960840 is a clinical study titled "Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL". This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and a...

What is the current status of trial NCT03960840?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2019-06-26. Estimated completion is 2028-05-31.

What conditions does trial NCT03960840 study?

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

What interventions are being tested in trial NCT03960840?

The interventions under investigation include: Ibrutinib (DRUG), Rapcabtagene autoleucel single agent (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03960840?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03960840 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Kansas, Massachusetts. 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