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Clinical Trial Summary

To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma.


Clinical Trial Description

CD19-targeted chimeric antigen receptor T-cell therapy has shown remarkable efficacy in relapsed or refractory B-cell malignancies. However, CD19 CAR-T cells are still unable to induce durable remissions in some patients. Further therapeutic strategies remain to be explored for patients who fail to achieve complete remission (CR) or who relapse after CAR-T treatment. the mechanisms underlying the failure of CAR-T cell therapy may be diverse and not yet fully understood. It may be due to the patient's own poor T-cell function, immunosuppressive tumour microenvironment, loss of tumour-targeting antigen expression with antitumour therapy, and compromised CAR-T renewal in vivo, or T-cell depletion due to the tumour microenvironment. It has recently been demonstrated that CAR-T cells become functionally depleted, or CAR lost, with sustained exposure to tumour antigen stimulation (Good, C, 2021). Extensive clinical experience suggests that CAR-T cell expansion and persistence are required to achieve a durable response. In patients requiring follow-up therapy after failure of the first CAR-T cell infusion (CART1), one option is a second infusion of CD19 CAR-T cells (CART2) for retreatment, and a second infusion of CD19 CAR-T cells (CART2) is considered a possible approach to improve prognosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05814848
Study type Interventional
Source Changhai Hospital
Contact Li Chen
Phone +8615026562366
Email yuhe0628@163.com
Status Not yet recruiting
Phase Phase 4
Start date June 20, 2023
Completion date March 31, 2028

See also
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Recruiting NCT03391726 - CART-19 Cells for R/R B-cell Lymphoma Phase 2/Phase 3
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Recruiting NCT05720052 - A Study of MS-553 in Patients With Relapsed or Refractory B-cell Lymphoma Phase 1/Phase 2
Recruiting NCT06045585 - JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma Early Phase 1