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NCT03960840 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Chronic Lymphocytic Leukemia and Acute Lymphoblastic Leukemia, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 1
Development phase
217
Enrollment target
20
Study locations

NCT03960840 is a Phase 1 study of Chronic Lymphocytic Leukemia and Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 217 participants, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT03960840, a Phase 1 study of Chronic Lymphocytic Leukemia and Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
217 participants
Enrollment target
20
Study locations

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

1,375 total trials

What the Registry Record Tells You About NCT03960840

The ClinicalTrials.gov registry entry for NCT03960840 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (20% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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.

NCT03960840 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Tennessee.

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, Diffuse Large B Cell Lymphoma, Small Lymphocytic Lymphoma, Large B-cell Lymphoma.

What interventions are being tested in trial NCT03960840?

The interventions under investigation include: Ibrutinib (DRUG), Rapcabtagene autoleucel single agent (BIOLOGICAL).

Who is sponsoring clinical trial NCT03960840?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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.

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

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