Phase I/II Study of Rapcabtagene Autoleucel in CLL, Advanced DLBCL, ALL, and High-Risk LBCL
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT03960840
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
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California LA | 90095 | Los Angeles | California |
| Stanford University Medical Center | 94305-5826 | Stanford | California |
| H Lee Moffitt Cancer Center and Research Institute | 33612 | Tampa | Florida |
| Northside Hospital | 30342 | Atlanta | Georgia |
| Northwestern University Northwestern Memorial Hospital Trans | 60611 | Chicago | Illinois |
| Uni of Chi Medi Ctr Hema and Onco | 60637 | Chicago | Illinois |
| University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Mass Gen Hosp Cancer Center | 02114 | Boston | Massachusetts |
| Montefiore Medical Center | 10461 | Bronx | New York |
| Oregon Health Sciences University | 97239 | Portland | Oregon |
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