NCT03754764

A Feasibility and Safety Study of CD38 CAR-T Cell Immunotherapy for Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T Adoptive Cellular Immunotherapy

Status unknown Phase 1, PHASE2 Last updated 7 December 2018

What this trial tests

Phase 1, PHASE2 trial testing Specificity CD38 CAR-T Cells in Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T ACI in 80 participants. Status unknown.

Timeline

23 November 2018

Primary endpoint
23 November 2022

23 November 2022

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	23 November 2018
Primary completion	23 November 2022
Estimated completion	23 November 2022
Sites	1 location across China

Drugs / interventions tested

• Specificity CD38 CAR-T Cells — full drug profile →

Conditions studied

• Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T ACI — all drugs for Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T ACI →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 12 to 70, any sex, with Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T ACI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. CD38 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD38. This is a phase 1/2 study designed to determine the safety of the gene-edited specificity CD38 CAR-T cells and the feasibility of making enough to treat patients with relapsed B-cell acute lymphoblastic leukemia after CD19 CAR-T adoptive cellular immunotherapy.

Publications & conference data

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

1. Targeting cancer stem cell pathways for cancer therapy.
   Yang L, Shi P, Zhao G, Xu J, et al · · 2020 · cited 1354× · PMID 32296030 · DOI 10.1038/s41392-020-0110-5
2. Engineered T Cell Therapy for Cancer in the Clinic.
   Zhao L, Cao YJ. · · 2019 · cited 275× · PMID 31681259 · DOI 10.3389/fimmu.2019.02250
3. Immune checkpoint blockade and CAR-T cell therapy in hematologic malignancies.
   Wang H, Kaur G, Sankin AI, Chen F, et al · · 2019 · cited 138× · PMID 31186046 · DOI 10.1186/s13045-019-0746-1
4. Facts and Challenges in Immunotherapy for T-Cell Acute Lymphoblastic Leukemia.
   Bayón-Calderón F, Toribio ML, González-García S. · · 2020 · cited 42× · PMID 33081391 · DOI 10.3390/ijms21207685
5. Challenges and Clinical Strategies of CAR T-Cell Therapy for Acute Lymphoblastic Leukemia: Overview and Developments.
   Xu X, Huang S, Xiao X, Sun Q, et al · · 2020 · cited 32× · PMID 33643279 · DOI 10.3389/fimmu.2020.569117
6. Novel BCMA-OR-CD38 tandem-dual chimeric antigen receptor T cells robustly control multiple myeloma.
   Feng Y, Liu X, Li X, Zhou Y, et al · · 2021 · cited 31× · PMID 34434610 · DOI 10.1080/2162402x.2021.1959102
7. Targeting CD38 in Neoplasms and Non-Cancer Diseases.
   Szlasa W, Czarny J, Sauer N, Rakoczy K, et al · · 2022 · cited 23× · PMID 36077708 · DOI 10.3390/cancers14174169
8. Infusion and delivery strategies to maximize the efficacy of CAR-T cell immunotherapy for cancers.
   Gu X, Zhang Y, Zhou W, Wang F, et al · · 2024 · cited 21× · PMID 39061100 · DOI 10.1186/s40164-024-00542-2