NCT04184414

The Clinical Application of Chimeric Antigen Receptor T Cells in the Treatment of CD19 Positive Recurrent Refractory B Cell-derived Hematological Malignancies

CD19-CART Cells in the Treatment of CD19+ r/r B Cell-derived Hematological Malignancies

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

CD19 is expressed in most B malignant tumors, especially in the former B cells ALL. This makes CD19 a natural target of immunotherapy. In terms of safety, the lack of B cells caused by CD19 targeted therapy will not cause life-threatening side effects (of course, Ig supplementation is necessary in the long-term B cell inhibition therapy). Moreover, the number of B cells can be restored after removing anti-CD19 treatment measures (such as anti-CD19 CART cells). In addition, CD19 has been chosen as the target of B-ALL therapy for the following reasons: ① as the BCR signal "amplifier", CD19 plays a role in PAX-5-mediated tumor formation; ② by activating MYC (as the oncogene controlled by PAX-5, C-MYC plays a key role in promoting the malignant proliferation of B cells), CD19 can cause B-ALL formation. Based on the above reasons, CD19 has become an ideal target in the treatment of B-cell cancer.

Conditions

• B Acute Lymphoblastic Leukemia
• Mantle Cell Lymphoma
• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	CD19-CART	1-10x106 / kg CD19 CART cells

Timeline

• Start date: 2018-01-09
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-12-03
• Last updated: 2019-12-03

Locations

1 site across 1 country: China