NCT03579888

CD19-Specific T Cells Post AlloSCT

Terminated Phase 1 Last updated 2 June 2021

What this trial tests

Phase 1 trial testing Autologous CD19-CD8-CD28-CD3zeta-CAR-mbIL15-HER1t T Cells in B Acute Lymphoblastic Leukemia With t(v;11q23.3); KMT2A Rearranged in 4 participants. Terminated before completion.

Timeline

26 June 2020

Primary endpoint
27 May 2021

27 May 2021

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	26 June 2020
Primary completion	27 May 2021
Estimated completion	27 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Autologous CD19-CD8-CD28-CD3zeta-CAR-mbIL15-HER1t T Cells — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →

Conditions studied

• B Acute Lymphoblastic Leukemia With t(v;11q23.3); KMT2A Rearranged — all drugs for B Acute Lymphoblastic Leukemia With t(v;11q23.3); KMT2A Rearranged →
• Recurrent B Acute Lymphoblastic Leukemia — all drugs for Recurrent B Acute Lymphoblastic Leukemia →
• Recurrent Chronic Lymphocytic Leukemia — all drugs for Recurrent Chronic Lymphocytic Leukemia →
• Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified — all drugs for Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 70, any sex, with B Acute Lymphoblastic Leukemia With t(v;11q23.3); KMT2A Rearranged or Recurrent B Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial investigates the side effects and best dose of CD19 positive (+) specific CAR-T cells in treating patients with CD19+ lymphoid malignancies, such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, small lymphocytic lymphoma, or chronic lymphocytic lymphoma. Sometimes researchers change the genetic material in the cells of a patient's T cells using a process called gene transfer. Researchers then inject the changed T-cells into the patient's body. Receiving the T-cell infusion may help to control the disease.

Publications & conference data

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

1. Scalable Manufacturing of CAR T cells for Cancer Immunotherapy.
   Abou-El-Enein M, Elsallab M, Feldman SA, Fesnak AD, et al · · 2021 · cited 217× · PMID 34568831 · DOI 10.1158/2643-3230.bcd-21-0084
2. Next generation chimeric antigen receptor T cells: safety strategies to overcome toxicity.
   Yu S, Yi M, Qin S, Wu K. · · 2019 · cited 208× · PMID 31429760 · DOI 10.1186/s12943-019-1057-4
3. Immunomodulatory Effects of IL-2 and IL-15; Implications for Cancer Immunotherapy.
   Yang Y, Lundqvist A. · · 2020 · cited 149× · PMID 33266177 · DOI 10.3390/cancers12123586
4. Engineered Cytokine Signaling to Improve CAR T Cell Effector Function.
   Bell M, Gottschalk S. · · 2021 · cited 108× · PMID 34177932 · DOI 10.3389/fimmu.2021.684642
5. Immune Dysfunctions and Immune-Based Therapeutic Interventions in Chronic Lymphocytic Leukemia.
   Griggio V, Perutelli F, Salvetti C, Boccellato E, et al · · 2020 · cited 54× · PMID 33312177 · DOI 10.3389/fimmu.2020.594556
6. Engineering Next-Generation CAR-T Cells for Better Toxicity Management.
   Andrea AE, Chiron A, Bessoles S, Hacein-Bey-Abina S. · · 2020 · cited 42× · PMID 33207607 · DOI 10.3390/ijms21228620
7. Transposon-Based CAR T Cells in Acute Leukemias: Where are We Going?
   Magnani CF, Tettamanti S, Alberti G, Pisani I, et al · · 2020 · cited 40× · PMID 32471151 · DOI 10.3390/cells9061337
8. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma.
   Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, et al · · 2021 · cited 36× · PMID 34515338 · DOI 10.1002/14651858.cd013365.pub2