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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, Large B-cell Lymphoma

In brief

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).

Key facts

Study ID

NCT03960840

Run by

Novartis Pharmaceuticals

People needed

217

Starts

2019-06-26

Expected to finish

2028-05-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status 0-1 for ALL and DLBCL
• ECOG performance status 0-2 for 1L HR LBCL at screening
• CLL or SLL diagnosis according to iwCLL criteria
• CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy
• DLBCL diagnosis by local histopathology
• DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
• Refractory or relapsed CD19-positive ALL
• ALL with morphologic disease in the bone marrow
• 1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis:
• IPI score of 3, 4 or 5
• MYC and BCL2 and/or BCL6 rearrangement (DH/TH lymphoma)
• Participants must have received 2 cycles of frontline therapy for LBCL with R-CHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received at least one cycle (the most recent) DA-EPOCH-R.
• Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and an overall response of PR/SD) after 2 cycles of frontline CIT. Note: Patient's with Deauville PET score of 5 and overall response of PD, or with Deauville PET score of 1, 2, or 3 and overall response of CR, are not eligible for this trial.

You may not qualify if…

• Prior CD19-directed therapy
• Prior administration of a genetically engineered cellular product
• Prior allogeneic HSCT
• Richter's transformation
• For 1L HR LBCL: Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, DLBCL associated with chronic inflammation, intravascular large B-cell lymphoma, ALK- positive large B-cell lymphoma, HHV8 positive LBCL, DLBCL leg type or EBV positive DLBCL, NOS.
• Active CNS lymphoma
• For 1L HR LBCL: Active or prior history CNS involvement by malignancy
• Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis
• Other protocol-defined inclusion/exclusion may apply.

Where it is running

• University of California LA — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Uni of Chi Medi Ctr Hema and Onco — Chicago, Illinois, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Mass Gen Hosp Cancer Center — Boston, Massachusetts, United States
• University of Pennsylvania Clinical — Philadelphia, Pennsylvania, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• St Davids South Austin Medical Ctr — Austin, Texas, United States
• Uni Of TX MD Anderson Cancer Cntr — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Pierre-Bénite, France
• Novartis Investigative Site — Rennes, France
• Novartis Investigative Site — Frankfurt am Main, Hesse, Germany
• Novartis Investigative Site — Leipzig, Saxony, Germany
• Novartis Investigative Site — Bergamo, BG, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Sapporo, Hokkaido, Japan

Full record on ClinicalTrials.gov

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