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

Description

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).

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

Phase I/II, Open Label, Multicenter Study of Rapcabtagene Autoleucel in Adult Patients With CLL/SLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

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

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California LA, Los Angeles, California, United States, 90095

Stanford

Stanford University Medical Center, Stanford, California, United States, 94305-5826

Tampa

H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States, 33612

Atlanta

Northside Hospital, Atlanta, Georgia, United States, 30342

Chicago

Northwestern University Northwestern Memorial Hospital Trans, Chicago, Illinois, United States, 60611

Chicago

Uni of Chi Medi Ctr Hema and Onco, Chicago, Illinois, United States, 60637

Westwood

University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Boston

Mass Gen Hosp Cancer Center, Boston, Massachusetts, United States, 02114

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10461

Philadelphia

University of Pennsylvania Clinical, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.
  • * 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2028-05-31