[Translation] A randomized, open-label, multicenter phase Ib clinical study of F0002-ADC in patients with relapsed/refractory CD30-positive peripheral T-cell lymphoma

主要目的：评价F0002-ADC在中国复发/难治性CD30阳性外周T细胞淋巴瘤患者中的初步疗效。次要目的：评价F0002-ADC在中国复发/难治性CD30阳性外周T细胞淋巴瘤患者中的安全性。评价F0002-ADC在中国复发/难治性CD30阳性外周T细胞淋巴瘤患者中的药代动力学特征及免疫原性。

[Translation]

Primary objective: To evaluate the preliminary efficacy of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive peripheral T-cell lymphoma. Secondary objective: To evaluate the safety of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive peripheral T-cell lymphoma. To evaluate the pharmacokinetic characteristics and immunogenicity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive peripheral T-cell lymphoma.

Start Date29 Nov 2021

Sponsor / Collaborator

Shanghai Jiaolian Drug Development Co. Ltd.

[+1]

CTR20190341 / RecruitingPhase 1

F0002-ADC在中国复发/难治性CD30阳性血液肿瘤患者中开展的一项剂量递增的安全耐受性、药代动力学和初步疗效的临床试验

[Translation] A dose-escalation clinical trial of the safety, tolerability, pharmacokinetics and preliminary efficacy of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematological malignancies

评价F0002-ADC在中国复发/难治性CD30阳性血液肿瘤患者中的最大耐受剂量和安全性特征，同时评价该药物在患者体内的药代动力学行为特征以及初步疗效和免疫原性。

[Translation]

To evaluate the maximum tolerated dose and safety profile of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematological malignancies, and to evaluate the pharmacokinetic behavior, preliminary efficacy and immunogenicity of the drug in patients.

Start Date24 Apr 2019

Sponsor / Collaborator

Shanghai Jiaolian Drug Development Co. Ltd.

[+1]

NCT03894150 / CompletedPhase 1

A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.

This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies.

Start Date11 Apr 2019

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

100 Clinical Results associated with Recombinant chimeric anti-CD30 monoclonal antibody-MCC-DM1(Shanghai Jiaolian Drug Development)

100 Translational Medicine associated with Recombinant chimeric anti-CD30 monoclonal antibody-MCC-DM1(Shanghai Jiaolian Drug Development)

100 Patents (Medical) associated with Recombinant chimeric anti-CD30 monoclonal antibody-MCC-DM1(Shanghai Jiaolian Drug Development)

Literatures (Medical) associated with Recombinant chimeric anti-CD30 monoclonal antibody-MCC-DM1(Shanghai Jiaolian Drug Development)

18 Aug 2019·mAbsQ2 · MEDICINE

Conjugation of DM1 to anti-CD30 antibody has potential antitumor activity in CD30-positive hematological malignancies with lower systemic toxicity

Q2 · MEDICINE

Article

Author: Li, Hua ; Guan, Lingyu ; Yang, Tong ; Jin, Li ; Zhao, Teng ; Guo, Qingsong ; Song, Ruiwen ; Wu, Jingsong ; Zhao, Li ; Zhang, Hengbin ; Wu, Guanghao ; Xu, Jun ; Gao, Bei ; Shen, Yijun ; Liu, Yanjun ; Yu, Helin ; Cai, Junli ; Yin, Sicheng ; Cao, Xuemei ; Su, Yong ; Zhang, Yifan

An anti-CD30 antibody-drug conjugate incorporating the antimitotic agent DM1 and a stable SMCC linker, anti-CD30-MCC-DM1, was generated as a new antitumor drug candidate for CD30-positive hematological malignancies. Here, the in vitro and in vivo pharmacologic activities of anti-CD30-MCC-DM1 (also known as F0002-ADC) were evaluated and compared with ADCETRIS (brentuximab vedotin). Pharmacokinetics (PK) and the safety profiles in cynomolgus monkeys were assessed. Anti-CD30-MCC-DM1 was effective in in vitro cell death assays using CD30-positive lymphoma cell lines. We studied the properties of anti-CD30-MCC-DM1, including binding, internalization, drug release and actions. Unlike ADCETRIS, anti-CD30-MCC-DM1 did not cause a bystander effect in this study. In vivo, anti-CD30-MCC-DM1 was found to be capable of inducing tumor regression in subcutaneous inoculation of Karpas 299 (anaplastic large cell lymphoma), HH (cutaneous T-cell lymphoma) and L428 (Hodgkin's disease) cell models. The half-lives of 4 mg/kg and 12 mg/kg anti-CD30-MCC-DM1 were about 5 days in cynomolgus monkeys, and the tolerated dose was 30 mg/kg in non-human primates, supporting the tolerance of anti-CD30-MCC-DM1 in humans. These results suggest that anti-CD30-MCC-DM1 presents efficacy, safety and PK profiles that support its use as a valuable treatment for CD30-positive hematological malignancies.

01 Jan 2017·Indian Journal of DermatologyQ4 · MEDICINE

New targeted treatments for cutaneous T-cell Lymphomas

Q4 · MEDICINE

ArticleOA

Author: Bagot, Martine

Cutaneous T-cell lymphomas (CTCLs) represent a group of rare and heterogeneous diseases that are very difficult to treat at advanced stages. The development of monoclonal antibodies is a new hope for the treatment of these diseases. Alemtuzumab (Campath) is a humanized IgG1 kappa monoclonal antibody specific for CD52, an antigen expressed by most T and B lymphocytes. Alemtuzumab may frequently induce long-term remissions in patients with Sezary syndrome but high-dose treatments lead to severe cytopenia, immune depletion, and opportunistic infections. This treatment is less efficient in mycosis fungoides (MF). Brentuximab vedotin is a chimeric anti-CD30 monoclonal antibody conjugated to monomethyl auristatin E, a cytotoxic antitubulin agent. Brentuximab vedotin is a very interesting new treatment for advanced tumor MF, Sezary syndrome, and primary cutaneous CD30+ lymphoproliferative disorders. The main limiting adverse event is neurosensitive peripheral neuropathy. Mogamulizumab is a humanized anti-C-C chemokine receptor Type 4 monoclonal antibody with a defucosylated Fc region leading to increased antibody-dependent cellular cytotoxicity. Mogamulizumab is very efficient on aggressive peripheral T-cell lymphomas, particularly adult T-cell leukemia/lymphoma and CTCLs, especially on the blood component of tumor cells. The main limiting events are related to the concomitant depletion of regulatory T-cells. IPH4102 is a humanized monoclonal antibody that targets the immune receptor KIR3DL2/CD158k. Preclinical results with this antibody offer proofs of concept for the clinical development of IPH4102 to treat patients with advanced CTCL.

01 Aug 2012·Therapeutic Advances in HematologyQ2 · MEDICINE

Safety and efficacy of brentuximab vedotin in patients with Hodgkin lymphoma or systemic anaplastic large cell lymphoma

Q2 · MEDICINE

ArticleOA

Author: Vaklavas, Christos ; Forero-Torres, Andres

Antibody-based immunotherapy has become an integral part of cancer therapeutics. However, monoclonal antibodies have their limitations as identifying an antigen selectively expressed on malignant cells and developing a high-affinity antibody may not by itself alter tumor growth. This is illustrated in the case of CD30; CD30 epitomizes many properties of an ideal pharmacologic target such as high expression on malignant cells and limited expression on normal tissues. However, until the advent of brentuximab vedotin, CD30 remained an elusive target as antibody-based anti-CD30 immunotherapy had been largely clinically unsuccessful. Brentuximab vedotin (cAC10-vcMMAE, SGN-35) is an antibody-drug conjugate consisting of a chimeric anti-CD30 monoclonal antibody whereupon the potent microtubule inhibitor monomethyl auristatin E (MMAE) is attached via a valine–citrulline linker. Once bound to CD30, brentuximab vedotin is internalized and MMAE is released with the action of lysosomal enzymes on the linker. In phase I studies in relapsed or refractory Hodgkin lymphoma and anaplastic large cell lymphoma, brentuximab vedotin induced unprecedented responses with manageable toxicity. In phase II studies, brentuximab vedotin induced overall response rates of 75% and 86% in relapsed or refractory Hodgkin lymphoma and anaplastic large cell lymphoma, respectively. The results of these trials led to the accelerated approval of the drug by the US Food and Drug Administration in a patient population with few other alternative options. Brentuximab vedotin has overall manageable toxicity profile; however, cumulative peripheral neuropathy constitutes an important clinical consideration as it may limit prolonged administration of the drug. The mechanism by which brentuximab vedotin exerts its antitumor activity is not entirely clear. Diffusion of MMAE in the tumor microenvironment and cytotoxicity on bystander cells may in part explain its activity, especially in Hodgkin lymphoma. Herein, we review the biology of CD30 and brentuximab vedotin, and the clinical data that has accumulated thus far with SGN-35.

100 Deals associated with Recombinant chimeric anti-CD30 monoclonal antibody-MCC-DM1(Shanghai Jiaolian Drug Development)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CD-30 positive Peripheral T-Cell Lymphoma	Phase 1	CN	Shanghai Jiaolian Drug Development Co. Ltd.	29 Nov 2021
CD-30 positive Peripheral T-Cell Lymphoma	Phase 1	CN	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	29 Nov 2021

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