NCT03302403

Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors

Status unknown NA Last updated 8 October 2020

What this trial tests

NA trial testing CAR-CD19 T cell in B Cell Lymphoma in 18 participants. Status unknown.

Timeline

29 December 2017

Primary endpoint
12 December 2020

12 December 2023

Quick facts

Lead sponsor	Kang YU
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	29 December 2017
Primary completion	12 December 2020
Estimated completion	12 December 2023
Sites	1 location across China

Drugs / interventions tested

• CAR-CD19 T cell
• CAR-BCMA T cell
• CAR-GPC3 T cell
• CAR-CLD18 T cell
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• B Cell Lymphoma — all drugs for B Cell Lymphoma →
• B Cell Leukemia — all drugs for B Cell Leukemia →
• Myeloma — all drugs for Myeloma →
• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Kang YU

Who can join

Adults 18 to 75, any sex, with B Cell Lymphoma or B Cell Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR T cells in patients with malignant tumors with positive antigen targets.

CAR T cells are genetically engineered to express single-chain variable fragment (scFv) targeting indication-specific antigens.

The investigational CAR T cells and proposed indications are as follows:

CAR-CD19 T cells for B cell leukaemia/lymphoma; CAR-BCMA T cells for myeloma; CAR-GPC3 T cell for hepatocellular carcinoma; CAR-CLD18 T cells for pancreatic carcinoma and adenocarcinoma of esophagogastric junction.

Publications & conference data

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

1. CAR T Cells for Solid Tumors: New Strategies for Finding, Infiltrating, and Surviving in the Tumor Microenvironment.
   Martinez M, Moon EK. · · 2019 · cited 653× · PMID 30804938 · DOI 10.3389/fimmu.2019.00128
2. BCMA-targeted immunotherapy for multiple myeloma.
   Yu B, Jiang T, Liu D. · · 2020 · cited 165× · PMID 32943087 · DOI 10.1186/s13045-020-00962-7
3. Recent advances in systemic therapy for hepatocellular carcinoma.
   Zhang H, Zhang W, Jiang L, Chen Y. · · 2022 · cited 150× · PMID 35000616 · DOI 10.1186/s40364-021-00350-4
4. Efficacy of anti-CD147 chimeric antigen receptors targeting hepatocellular carcinoma.
   Tseng HC, Xiong W, Badeti S, Yang Y, et al · · 2020 · cited 150× · PMID 32968061 · DOI 10.1038/s41467-020-18444-2
5. Safety and clinical efficacy of BCMA CAR-T-cell therapy in multiple myeloma.
   Roex G, Timmers M, Wouters K, Campillo-Davo D, et al · · 2020 · cited 137× · PMID 33272302 · DOI 10.1186/s13045-020-01001-1
6. Glypican-3: A New Target for Diagnosis and Treatment of Hepatocellular Carcinoma.
   Guo M, Zhang H, Zheng J, Liu Y. · · 2020 · cited 121× · PMID 32127929 · DOI 10.7150/jca.39972
7. Engineering enhanced CAR T-cells for improved cancer therapy.
   Milone MC, Xu J, Chen SJ, Collins MA, et al · · 2021 · cited 111× · PMID 34485921 · DOI 10.1038/s43018-021-00241-5
8. Glypican 3-Targeted Therapy in Hepatocellular Carcinoma.
   Nishida T, Kataoka H. · · 2019 · cited 102× · PMID 31510063 · DOI 10.3390/cancers11091339