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

Active Not RecruitingPhase 1, Phase 2

Sponsor: Novartis Pharmaceuticals

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

Interventions: Rapcabtagene autoleucel single agent, Ibrutinib

Countries: United States, Australia, Austria, France, Germany, Italy, Japan, Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (37)

Los Angeles, California, United States
Stanford, California, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Westwood, Kansas, United States
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Vienna, Austria
Marseille, France
Paris, France
Pierre-Bénite, France
Rennes, France
Frankfurt am Main, Hesse, Germany
Leipzig, Saxony, Germany
Bergamo, BG, Italy
Milan, MI, Italy
Rozzano, MI, Italy
Sapporo, Hokkaido, Japan
Bunkyo Ku, Tokyo, Japan
Fukuoka, Japan
Badalona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Barcelona, Spain
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