NCT04650724

Clinical Study of T Cell Infusion Targeting BCMA Chimeric Antigen Receptor

Completed EARLY_PHASE1 Last updated 3 December 2020

What this trial tests

EARLY_PHASE1 trial testing T cell infusion agent targeting BCMA chimeric antigen receptor in Multiple Myeloma in 3 participants. Completed in 1 October 2020.

Timeline

11 October 2018

Primary endpoint
20 December 2018

1 October 2020

Quick facts

Lead sponsor	PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	11 October 2018
Primary completion	20 December 2018
Estimated completion	1 October 2020
Sites	1 location across China

Drugs / interventions tested

• T cell infusion agent targeting BCMA chimeric antigen receptor — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd. — full company profile →

Who can join

Adults 14 to 65, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.

BCMA is a specific surface protein of B lymphocytes, which plays an important role in the development, proliferation and differentiation of B cells. BCMA is highly expressed in malignant mm plasma cells and provides a large number of anti apoptotic signals, which makes bcam an ideal target in targeted immunotherapy. At present, a variety of immunotherapy strategies targeting BCMA are being carried out in laboratory and clinical practice, which have achieved encouraging therapeutic effects in multiple myeloma and effectively promoted the development of targeted immunotherapy.

Publications & conference data

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

1. Patient selection for CAR T or BiTE therapy in multiple myeloma: Which treatment for each patient?
   Kegyes D, Constantinescu C, Vrancken L, Rasche L, et al · · 2022 · cited 53× · PMID 35672793 · DOI 10.1186/s13045-022-01296-2
2. Mechanisms of Action and Limitations of Monoclonal Antibodies and Single Chain Fragment Variable (scFv) in the Treatment of Cancer.
   Rodríguez-Nava C, Ortuño-Pineda C, Illades-Aguiar B, Flores-Alfaro E, et al · · 2023 · cited 45× · PMID 37371712 · DOI 10.3390/biomedicines11061610
3. Successful Treatment of Relapsed/Refractory Extramedullary Multiple Myeloma With Anti-BCMA CAR-T Cell Therapy Followed by Haploidentical Hematopoietic Stem Cell Transplantation: A Case Report and a Review of the Contemporary Literature.
   Qian Y, Qian Z, Zhao X, Pan W, et al · · 2021 · cited 12× · PMID 34026784 · DOI 10.3389/fmed.2021.649824
4. CAR-modified immune cells as a rapidly evolving approach in the context of cancer immunotherapies.
   Faeq MH, Al-Haideri M, Mohammad TAM, Gharebakhshi F, et al · · 2023 · cited 7× · PMID 37083979 · DOI 10.1007/s12032-023-02019-4