The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies

Start Date04 May 2022

Sponsor / Collaborator

Shanghai First People's Hospital

NCT04599556 / RecruitingPhase 1IIT

Clinical Trial for the Safety and Efficacy of Anti-CD7 Chimeric Antigen Receptor Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).

Start Date01 Apr 2021

Sponsor / Collaborator

Zhejiang University

[+1]

NCT04572308 / CompletedPhase 1

Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (TLBL).

Start Date01 Oct 2020

Sponsor / Collaborator

Hebei Senlangbio Biotechnology Co., Ltd.

100 Clinical Results associated with CD7 Positive T-Cell Leukemia

100 Translational Medicine associated with CD7 Positive T-Cell Leukemia

0 Patents (Medical) associated with CD7 Positive T-Cell Leukemia

Literatures (Medical) associated with CD7 Positive T-Cell Leukemia

01 Jul 2022·Clinical Cancer ResearchQ1 · MEDICINE

Autologous Nanobody-Derived Fratricide-Resistant CD7-CAR T-cell Therapy for Patients with Relapsed and Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma

Q1 · MEDICINE

Article

Author: Zhang, Mingzhi ; Chen, YuSheng ; Wu, Xiaolong ; Xu, Hanying ; Chen, Dan ; Wang, Xinhua ; Li, Jiwei ; Yang, Lin ; Xiang, Shufen ; Wang, Yinyan ; Yu, Hui ; Meng, Huimin ; Zhang, Lei ; Nan, Feifei ; Li, Ling ; Fu, Xiaorui ; Yan, Jiaqin ; You, Fengtao ; Li, Zhaoming ; Zhang, Bozhen ; Wang, Yu ; Sun, Zhenchang ; Wang, Min ; Zhou, Zhiyuan ; Pan, Guifang ; Chang, Yu ; Li, Xin

AbstractPurpose:Since CD7 may represent a potent target for T-lymphoblastic leukemia/lymphoma (T-ALL/LBL) immunotherapy, this study aimed to investigate safety and efficacy of autologous CD7–chimeric antigen receptor (CAR) T cells in patients with relapsed and refractory (R/R) T-ALL/LBL, as well as its manufacturing feasibility.Patients and Methods:Preclinical phase was conducted in NPG mice injected with Luc+ GFP+CCRF-CEM cells. Open-label phase I clinical trial (NCT04004637) enrolled patients with R/R CD7-positive T-ALL/LBL who received autologous CD7-CAR T-cell infusion. Primary endpoint was safety; secondary endpoints included efficacy and pharmacokinetic and pharmacodynamic parameters.Results:CD7 blockade strategy was developed using tandem CD7 nanobody VHH6 coupled with an endoplasmic reticulum/Golgi-retention motif peptide to intracellularly fasten CD7 molecules. In preclinical phase CD7 blockade CAR T cells prevented fratricide and exerted potent cytolytic activity, significantly relieving leukemia progression and prolonged the median survival of mice. In clinical phase, the complete remission (CR) rate was 87.5% (7/8) 3 months after CAR T-cell infusion; 1 patient with leukemia achieved minimal residual disease–negative CR and 1 patient with lymphoma achieved CR for more than 12 months. Majority of patients (87.5%) only had grade 1 or 2 cytokine release syndrome with no T-cell hypoplasia or any neurologic toxicities observed. The median maximum concentration of CAR T cells was 857.2 cells/μL at approximately 12 days and remained detectable up to 270 days.Conclusions:Autologous nanobody-derived fratricide-resistant CD7-CAR T cells demonstrated a promising and durable antitumor response in R/R T-ALL/LBL with tolerable toxicity, warranting further studies in highly aggressive CD7-positive malignancies.

01 Aug 2020·Zhongguo shi yan xue ye xue za zhi

[Killing Effect of A CD7 Chimeric Antigen Receptor-Modified NK-92MI Cell Line on CD7-Positive Hematological Malignant Cells].

Article

Author: Yang, Lin ; Wang, Xing-Bing ; Liu, Na-Na ; Pan, Gui-Fang ; Wang, Min ; You, Feng-Tao ; Liu, Xin ; Zhu, Xin-Ying ; Wang, An-You

OBJECTIVETo investigate the killing effect of NK-92MI cells modified by chimeric antigen receptor (CD7-CAR) and specifically targeting CD7 to CD7⁺ hematological malignant cells.METHODSThree types of hematological malignant tumor cells, including 5 cases of CD7⁺ acute T-lymphoblastic leukemia (T-ALL), 10 cases of acute myeloid leukemia (AML) and 6 cases of T-cell lymphoma were collected, centrifuged, cultured and used to detect the expression levels of tumor cell surface targets; 7-AAD, CD56-APC, CD3-FITC, IgG Fc-PE flow cytometry were used to detected the transfection efficiency of NK-92MI and CD7-CAR-NK-92MI cells, killing efficiencies of CD7-CAR-NK-92MI cells to CD7⁺ hematological tumor cells in vitro were determined by flow cytometry using PE Annexin V Apoptosis Detection Kit. Secretion differences of NK-92MI and CD7-CAR-NK-92MI cytokines interleukin (IL)-2, interferon (IFN)-γ, and granzyme B detection were estimated by using CBA kit.RESULTSThe killing efficiencies of CD7-CAR-modified NK-92MI cells to CD7⁺ T-ALL, AML, T-cell lymphoma tumor cells were significantly higher than those of NK-92MI cells without genetical modification. The difference showed statistically significant (P＜0.05). The level of IFN-γ and granzyme B were significantly increased among cytokines secreted by CD7-CAR-modified NK-92MI cells as compared with those of NK-92MI cells without genetical modification (P＜0.05) .CONCLUSIONCD7-CAR-modified NK-92MI cells have significantly improved killing efficiency against CD7⁺ T-ALL, AML and T lymphoma cells, and shows specific targeting effects, which provides a clinical basis for the treatment of CD7⁺ hematological malignancies.

01 Dec 2019·Best Practice & Research Clinical HaematologyQ4 · MEDICINE

Chimeric antigen receptor T cells (CAR-T) for the treatment of T-cell malignancies

Q4 · MEDICINE

Review

Author: Cooper, Mathew L ; DiPersio, John F

At present, the only curative therapy for patients with T-cell malignancies is allogeneic stem cell transplant, which has associated risks and toxicities. Novel agents have been tried in relapsed T-cell acute lymphoblastic leukemia (T-ALL), but only one, with 20%-30% complete remission rates, has been approved by the US Food and Drug Administration. T-ALL is a heterogeneous disease, but it has universal overexpression of CD7 as well as several other T-cell markers, such as CD2 and CD5. T cells engineered to express a chimeric antigen receptor (CAR) are a promising cancer immunotherapy. Such targeted therapies have shown great potential for inducing both remissions and even long-term relapse-free survival in patients with B-cell leukemia and lymphoma. UCART7 for CD7⁺ T-cell malignancies is in development for treatment of relapsed T-ALL in children and adults. It may also have potential in other CD7⁺ hematologic malignancies that lack both effective therapies and targeted therapies. The challenges encountered and progress made in developing a novel fratricide-resistant "off-the-shelf" CAR-T (or UCART7) that targets CD7⁺ T-cell malignancies are discussed here.

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