Phase I/II Study of Rapcabtagene Autoleucel in CLL, Advanced DLBCL, ALL, and High-Risk LBCL

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03960840

Provider View

This clinical trial is testing a new treatment called rapcabtagene autoleucel, alone or with ibrutinib, for different types of blood cancers, including CLL, DLBCL, ALL, and high-risk LBCL. The study aims to see if this treatment is safe and effective in shrinking tumors.

Patient Parameters

Program Overview

The study is exploring the safety and effectiveness of a new treatment, rapcabtagene autoleucel (YTB323), for various blood cancers. It is being tested alone or with another drug, ibrutinib, in patients with chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute lymphoblastic leukemia (ALL), and high-risk large B-cell lymphoma (LBCL).

Description

This clinical trial is divided into two phases, Phase I and Phase II, and is being conducted at multiple centers.

In Phase I, there are three treatment groups:

  • Rapcabtagene autoleucel combined with ibrutinib for adults with CLL/SLL who have stable disease or partial response after at least 6 months of ibrutinib treatment. Enrollment for this group is complete.
  • Rapcabtagene autoleucel alone for adults with DLBCL who have not responded to at least two chemotherapy treatments and have either relapsed after a stem cell transplant or are not eligible for it.
  • Rapcabtagene autoleucel alone for adults with relapsed or refractory ALL.

In Phase II, there are two groups:

  • Rapcabtagene autoleucel alone for adults with advanced DLBCL who have not responded to at least two chemoimmunotherapy treatments and have either relapsed after a stem cell transplant or are not eligible for it. This group continues from Phase I.
  • Rapcabtagene autoleucel alone for newly diagnosed adults with high-risk LBCL who have completed 2 cycles of initial treatment and have a partial or stable response.

The study will determine the best dose of rapcabtagene autoleucel and assess its safety and effectiveness. Participants will be monitored for at least 2 years for safety and effectiveness, and then for up to 15 years for long-term safety related to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults with a performance status of 0-1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Diagnosed with CLL or SLL and have stable disease or partial response after at least 6 months of ibrutinib treatment.
  • Diagnosed with DLBCL that has relapsed or is refractory after 2 or more treatments, including stem cell transplant.
  • Diagnosed with refractory or relapsed CD19-positive ALL with disease in the bone marrow.
  • Newly diagnosed high-risk LBCL with specific risk factors, such as an IPI score of 3-5 or certain genetic rearrangements.
  • Have received 2 cycles of initial treatment for LBCL and have a specific PET scan result indicating partial or stable response.

Exclusion Criteria

  • Previous treatment with CD19-directed therapy.
  • Previous treatment with a genetically engineered cellular product.
  • Previous allogeneic stem cell transplant.
  • Certain types of lymphoma, such as Richter's transformation or Burkitt lymphoma, for high-risk LBCL group.
  • Active lymphoma in the central nervous system.
  • Recent use of certain targeted therapies within 2 weeks before blood cell collection for the study.

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