Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT05948033
Brief Summary:
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Detailed Description:
CAR-T cell therapy has been identified as a breakthrough therapy in hematologic malignancies,especially anti-CD19 CAR-T cell therapy in the treatment of r/r B-NHL has achieved remarkable efficacy.However, relapse with CD19-negative tumor after treatment with anti-CD19 CAR-T cells has been reported in different types of B-cell lymphoid malignancies, with a percentage up to 38% in patients with non-Hodgkin lymphoma (NHL).At present, the CAR-T cell treatment for HL is mainly confined to CD30 antigen,with an objective response rate (ORR) only 38%\~62%. Therefore, a more effective treatment strategy is needed for these patients.
CD70, the membrane-binding ligand of the CD27 (a tumor necrosis factor receptor superfamily), has been reported to mediate tumour cell proliferation and be expressed on the malignant cells of diffuse large B-cell lymphoma (DLBCL)，mantle cell lymphoma (MCL) and follicular lymphomas (FL), as well as Hodgkin lymphoma, etc,but rarely on normal B cells or T cells,indicating CD70 targeted treament has emerged as potentialnovel immunotherapeutic strategy.Preclinical study demonstrated CD70-CAR-T cells represent a new therapeutic option for the treatment of patients with CD19-negative recurrence of lymphoma.Based on the preclinical data, we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD70-CAR-T cells in vivo. In dose escalation period, at least 12 eligible patients will be enrolled and receive 3 doses of CD70-CAR-T cell therapy (1 × 10\^6 cells/kg, 3 × 10\^6 cells/kg, 1 × 10\^7 cells/kg) according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell infusion at dose of RP2D, which is determined by data from dose escalation period, including occurrence of dose limiting toxicities(DLT), pharmacokinetics/pharmacodynamics, efficacy and other parameters, to furtherly evaluate the safety and efficacy profiles of CD70-CAR-T cell therapy.
Study:
NCT05948033
Study Brief:
Protocol Section:
NCT05948033