Clinical Trial

Disease: Relapsed or Refractory B-cell Malignancies, (NCT06014762)

Disease info:

B-cell malignancies are cancers that arise from abnormalities in B cells, and include B-cell lymphomas and leukaemias. While leukaemias typically originate in the bone marrow and spread through the bloodstream, lymphomas usually originate in the lymph nodes or the spleen and spread through the lymphatic system.

There are more than 70 known types of B-cell lymphoma, and these make up approximately 85 % of all cases of non-Hodgkin lymphomas in the United States. NHL is one of the most common cancers in the United States, accounting for about 4% of all cancers. B-cell lymphomas may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. Other common types of B-cell lymphoma include:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma
  • Chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL)
  • Mantle cell lymphoma (MCL)
  • Marginal zone lymphomas
  • Burkitt lymphoma

In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. B-ALL is the most common type of ALL. Note that B-ALL is also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia.

NHL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,550 people will be diagnosed with NHL in 2023. ALL accounts for less than 1% of all cancers in the U.S., with around 6,540 new cases estimated in 2023.
Official title:
Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies


Name: Angie Schinkel

Phone: 858-779-3103





United States, California

University of California San Diego, La Jolla, California, United States, 92093

Loma Linda University Cancer Center, Loma Linda, California, United States, 92354


United States, Michigan

Wayne State - Karmanos Cancer Institute, Detroit, Michigan, United States, 48201


United States, New York

Weill Cornell Medicine, New York, New York, United States, 10021


United States, North Carolina

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States, 27599


United States, Ohio

University of Cincinnati, Cincinnati, Ohio, United States, 45206


United States, Oklahoma

University of Oklahoma, Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104


United States, South Carolina

Prisma Health - Upstate Cancer Institute, Greenville, South Carolina, United States, 29605


United States, Tennessee

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232


United States, Texas

Baylor Scott & White Research Institute, Dallas, Texas, United States, 75204

Study start:
Dec. 1, 2023
70 participants
Gene editing method:
Type of edit:
Gene disruption
T cell receptor beta (TRB) and Beta-2-Microglobulin (B2M)
Delivery method:
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


Phase 1 study consisting of two parts. Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts to determine a Recommended Phase 2 Dose (RP2D). Part 2 includes administration at a fixed dose. After enrollment, subjects may receive a lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered as a single dose. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.

Last updated: Jan. 28, 2024
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