[Translation] Phase I/II clinical study on the safety, tolerability and anti-tumor efficacy of KACM001 autologous lymphocyte injection combined with S-1/Oxaliplatin or Cisplatin in the treatment of locally advanced unresectable or metastatic gastric cancer

I期研究主要研究目的：评价局部晚期不可切除或转移性胃癌受试者化疗期间接受KACM001自体淋巴细胞注射液的安全性和耐受性，并探索MTD（最大耐受剂量）和/或RP2D（II期临床研究推荐剂量）。次要研究目的：初步评价KACM001自体淋巴细胞注射液联合化疗的抗肿瘤疗效。探索性研究目的：探索KACM001自体淋巴细胞注射液输注后在体内的特征参数。 II期研究主要研究目的：评价KACM001自体淋巴细胞注射液对局部晚期不可切除或转移性胃癌的抗肿瘤疗效。次要研究目的：评价KACM001自体淋巴细胞注射液对局部晚期不可切除或转移性胃癌的其他抗肿瘤疗效。评价KACM001自体淋巴细胞注射液对局部晚期不可切除或转移性胃癌的安全性及耐受性。

[Translation]

Phase I study Main study objective: To evaluate the safety and tolerability of KACM001 autologous lymphocyte injection during chemotherapy in subjects with locally advanced unresectable or metastatic gastric cancer, and to explore the MTD (maximum tolerated dose) and/or RP2D (recommended dose for Phase II clinical studies). Secondary study objective: To preliminarily evaluate the anti-tumor efficacy of KACM001 autologous lymphocyte injection combined with chemotherapy. Exploratory study objective: To explore the characteristic parameters of KACM001 autologous lymphocyte injection in vivo after infusion. Phase II study Main study objective: To evaluate the anti-tumor efficacy of KACM001 autologous lymphocyte injection on locally advanced unresectable or metastatic gastric cancer. Secondary study objective: To evaluate other anti-tumor efficacy of KACM001 autologous lymphocyte injection on locally advanced unresectable or metastatic gastric cancer. To evaluate the safety and tolerability of KACM001 autologous lymphocyte injection on locally advanced unresectable or metastatic gastric cancer.

Start Date21 Sep 2023

Sponsor / Collaborator

Beijing Biohealthcare Biotechnology Co., Ltd.

NCT02965157 / Unknown statusPhase 1/2

Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma

Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Start Date01 Aug 2016

Sponsor / Collaborator

Beijing Biohealthcare Biotechnology Co., Ltd.

NCT02504229 / Unknown statusPhase 2

DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment

This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.

Start Date01 Nov 2014

Sponsor / Collaborator

Beijing Biohealthcare Biotechnology Co., Ltd.

100 Clinical Results associated with Beijing Biohealthcare Biotechnology Co., Ltd.

0 Patents (Medical) associated with Beijing Biohealthcare Biotechnology Co., Ltd.

Literatures (Medical) associated with Beijing Biohealthcare Biotechnology Co., Ltd.

01 Dec 2021·Investigational New DrugsQ3 · MEDICINE

IL-15-induced lymphocytes as adjuvant cellular immunotherapy for gastric cancer

Q3 · MEDICINE

Article

Author: Zhang, Wen ; Piao, Chunmei ; Liu, Dong ; Cui, Peilin ; Liu, Jingwei ; Chen, Hao ; Lu, Xu ; Lu, Yongcheng ; Liu, Xuesong ; Hu, Yuefeng ; Wang, Yue

Objectives To test the antitumor potential of lymphocytes transferred via adoptive cell therapy (ACT) in a mouse model of human gastric cancer (GC), and to evaluate the clinical efficacy and safety of combining lymphocytes as adjuvant therapy with first-line chemotherapy in patients with GC. Methods We constructed a human GC xenograft model in sublethally irradiated 6-8-week-old male NCG mice. MKN-45 cells (1 × 10⁶ cells/mouse) were subcutaneously injected into mice's flanks. After tumors had become palpable, we randomized the mice into control, ACT^IL-2, and ACT^IL-15 groups. Human lymphocytes were then injected into mouse tail veins. In addition, 63 human patients with histologically or cytologically confirmed stage III-IV GC randomly received S-1 + oxaliplatin + ACT^IL-15 (combination therapy group) or S-1 + oxaliplatin (chemotherapy group). Results In the mouse study, treatment with ACT^IL-15 cells inhibited tumor growth on adoptive transfer, and mice that received ACT^IL-15 cells had significantly longer survival rates (p < 0.05, ACT^IL-15 vs. ACT^IL-2). In the human study, the median survival rate of patients in the combination therapy group was 472 days (95% confidence interval [CI], 276-668 days), whereas that of patients in the chemotherapy group was 266 days (95% CI, 200-332 days; p < 0.05). Eleven percent (7/63) of patients had adverse reactions, but these reactions did not interfere with treatment. Conclusion Adoptive transfer of ACT^IL-15 cells in a mouse model of GC and in patients with advanced GC treated with S1 + oxaliplatin improved survival rates in both, with an acceptable safety profile.

01 Feb 2020·Cellular ImmunologyQ3 · MEDICINE

Synergistic effect of adoptive immunotherapy and docetaxel inhibits tumor growth in a mouse model

Q3 · MEDICINE

Article

Author: Xiao, Man ; Piao, Chunmei ; Lu, Xu ; Liu, Tao ; Xu, Xianghong ; Cui, Peilin ; Lu, Yongcheng ; Zhang, Qike ; Hu, Yuefeng ; Liu, Jingwei ; Wang, Yue ; Liu, Xuesong

Adoptive T cell transfer therapy (ACT) has emerged as a promising approach to cancer immunotherapy; however, the efficacy of ACT is limited by the T-cell suppressive activity of myeloid-derived suppressor cells (MDSCs), which accumulate in the tumor microenvironment after ACT. We sought to determine whether the efficacy of ACT could be enhanced by co-treatment with docetaxel, a taxane chemotherapy agent that has been shown previously to inhibit MDSC function. Using a mouse tumor model, we demonstrated that ACT and docetaxel synergistically inhibit the growth either of engrafted CT26 colon cancer or 4T1 mammary carcinoma cells. While ACT mediated an increase in the recruitment of MDSCs to the site of the tumor, docetaxel reversed this increase. Furthermore, ex vivo cultures of tumor-associated MDSCs suppressed the cytotoxic activity of tumor-specific T cells, and this suppressive activity was abolished by docetaxel treatment. These results suggest that docetaxel inhibits both the tumor recruitment and T cell suppressive activity of MDSCs. Inhibitors of iNOS and arginase partially inhibited ex vivo MDSC activity, and combined inhibition of iNOS and arginase had a similar effect as docetaxel, which supports the possibility that docetaxel may function by inhibiting ACT-associated activation of these pathways. Furthermore, docetaxel mediated inhibition of the T cell suppressive activity of MDSCs from human blood, which supports the potential clinical applicability of these findings. On the basis of these findings, docetaxel treatment may represent an effective therapeutic approach for reversing immunosuppression by MDSCs subsequent to ACT-based therapy.

01 Jan 2019·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

Phase I/II clinical trial of a Wilms’ tumor 1-targeted dendritic cell vaccination-based immunotherapy in patients with advanced cancer

Q2 · MEDICINE

Article

Author: Piao, Chunmei ; Yang, Lin ; Wang, Yue ; Cui, Peilin ; Zhang, Wen ; Liu, Jingwei ; Xiao, Man ; Wu, Xuan ; Lu, Xu ; Liu, Xuesong

Dendritic cell (DC)-based immunotherapies have been created for a broad expanse of cancers, and DC vaccines prepared with Wilms' tumor protein 1 (WT1) peptides have shown great therapeutic efficacy in these diseases. In this paper, we report the results of a phase I/II study of a DC-based vaccination for advanced breast, ovarian, and gastric cancers, and we offer evidence that patients can be effectively vaccinated with autologous DCs pulsed with WT1 peptide. There were ten patients who took part in this clinical study; they were treated biweekly with a WT1 peptide-pulsed DC vaccination, with toxicity and clinical and immunological responses as the principal endpoints. All of the adverse events to DC vaccinations were tolerable under an adjuvant setting. The clinical response was stable disease in seven patients. Karnofsky Performance Scale scores were enhanced, and computed tomography scans revealed tumor shrinkage in three of seven patients. Human leukocyte antigen (HLA)/WT1-tetramer and cytoplasmic IFN-γ assays were used to examine the induction of a WT-1-specific immune response. The immunological responses to DC vaccination were significantly correlated with fewer myeloid-derived suppressor cells (P = 0.045) in the pretreated peripheral blood. These outcomes offered initial clinical evidence that the WT1 peptide-pulsed DC vaccination is a potential treatment for advanced cancer.

100 Deals associated with Beijing Biohealthcare Biotechnology Co., Ltd.

100 Translational Medicine associated with Beijing Biohealthcare Biotechnology Co., Ltd.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

KACM-002	Liver Cancer More	Phase 1
Autologous lymphocyte therapy (Biohealthcare)	Hepatocellular Carcinoma More	IND Approval
KAS03	Liver Cirrhosis More	Preclinical
KAS01	Osteoarthritis, Knee More	Preclinical
KACM005	Epstein-Barr Virus Infections More	Preclinical

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