NCT03768310

Phase I Study of the Administration of CD19 Chimeric Antigen Receptor Multivirus-Specific Cytotoxic T Lymphocytes for Prophylaxis or Therapy of Relapse of CD19 Positive Malignancies After Allogeneic Hematopoietic Stem Cell Transplantation

Withdrawn Phase 1 Last updated 19 July 2022

What this trial tests

Phase 1 trial testing CD19.CAR-multiVST for Group A in Non-hodgkin Lymphoma. Withdrawn.

Timeline

1 June 2022

Primary endpoint
1 August 2025

1 August 2040

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	1 June 2022
Primary completion	1 August 2025
Estimated completion	1 August 2040
Sites	2 locations across United States

Drugs / interventions tested

• CD19.CAR-multiVST for Group A — full drug profile →
• CD19.CAR-multiVST for Group B — full drug profile →

Conditions studied

• Non-hodgkin Lymphoma — all drugs for Non-hodgkin Lymphoma →
• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →

Sponsor

Baylor College of Medicine

Who can join

Adults 1 to 75, any sex, with Non-hodgkin Lymphoma or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients with Dose-Limiting Toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  Time frame: 6 weeks
  DLT will be defined as any of the following that is NOT (1) pre-existing, or (2) due to infection (for which patients with B-ALL, B-Lly, and B-NHL are predisposed), or (3) due to underlying malignancy, and that may, after consultation with the FDA when indicated, be considered possibly, probably, or definitely related to the study cellular products. * Any Grade 5 event * Non-hematologic DLT is an

Sponsor's own description

This study is for patients that are having a bone marrow or stem cell transplant for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called Non-Hodgkin's Lymphoma (NHL). Although a transplant can cure leukemia or lymphoma, some people will relapse (return of the disease). In those who relapse, current treatment cures only a very small percentage. This study is being conducted to evaluate the safety of a new type of therapy that may help to decrease the risk of relapse or treat relapse after it has occurred.

The body has different ways of fighting infection and disease. This study combines two of those ways, antibodies and T cells. Antibodies are proteins that protect the body from bacterial and other diseases. T cells are infection-fighting blood cells that can kill other cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients.

The antibody used in this study is called anti-CD19. This antibody is attracted to cancer cells because of a substance on the outside of these cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor (also known as a CAR T cell). Although anti-CD19 antibodies or chimeric receptors can kill cancer cells, unfortunately they sometimes do not last long enough to destroy all of the cancer cells.

These CD19 chimeric receptor multivirus specific T cells are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to find the biggest dose of chimeric T cells that is safe to administer, to determine what the side effects are, to see how long the T cells last and to evaluate whether this therapy might help prevent infections and relapse in people with CD19+ leukemia or lymphoma having a bone marrow transplant.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways in the regulation of cancer stem cells and associated targeted therapy.
   Manni W, Min W. · · 2022 · cited 52× · PMID 36226253 · DOI 10.1002/mco2.176
2. Advances in immunotherapeutic targets for childhood cancers: A focus on glypican-2 and B7-H3.
   Li N, Spetz MR, Li D, Ho M. · · 2021 · cited 15× · PMID 33992682 · DOI 10.1016/j.pharmthera.2021.107892
3. Allogeneic Chimeric Antigen Receptor Therapy in Lymphoma.
   Khurana A, Lin Y. · · 2022 · cited 14× · PMID 35212892 · DOI 10.1007/s11864-021-00920-6
4. Alloreactive-free CAR-VST therapy: a step forward in long-term tumor control in viral context.
   Wang V, Savoldo B, Guimaraes JA, Dotti G, et al · · 2024 · cited 1× · PMID 39882248 · DOI 10.3389/fimmu.2024.1527648