Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Neoplasm Metastasis

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplastic Processes

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Infusion of CD70-targeted CAR-T cells by dose of 1-10x106 cells/kg

Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

CD70 CAR-T cells

Jingwang Bi, M.D

Jingwang Bi, MD

Jianfeng Bi, M.D

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with advanced/metastatic renal cell carcinoma, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

This is a single-center, single-arm, open-label study. Intravenous infusion group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic renal cell carcinoma in Dose discovery phase and 12 subjects in dose expansion phase.

Clinical Study of CD70-targeted CAR-T Therapy for Advanced/Advanced Renal Cancer

A Phase I Clinical Study of CD70-targeted CAR-T Therapy for Advanced/Advanced Renal Cancer

assessment the correlation between CD70 positive rate and the incidence of CRA and ICANS

assessment the correlation between CD70 positive rate and the disease control rate，Disease control rate: including CR, PR and SD

OS will be assessed from the first CD70-CAR-T cell infusion to death from any cause (Assessed by investigators based on IRECIST criteria)

PFS will be assessed from the first CD70-CAR-T cell infusion to death from any cause or the first assessment of progression (Assessed by investigators based on IRECIST criteria)

DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause (Assessed by investigators based on IRECIST criteria)

Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Dose-limiting toxicity after cell infusion

Disease control rate: including CR, PR and SD(Assessed based on RECIST criteria)

Objective response rate includes：CR、PR(Assessed based on RECIST criteria)

DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause

OS will be assessed from the first CD70-CAR-T cell infusion to death from any cause (Assessed based on RECIST criteria)

PFS will be assessed from the first CD70-CAR-T cell infusion to death from any cause or the first assessment of progression(Assessed based on RECIST criteria)

AUCS is defined as the area under the curve in 90 days

CMAX is defined as the highest concentration of CD70 CAR-T cells expanded in peripheral blood

TMAX is defined as the time to reach the highest concentration

Concentration levels of CAR-T-related serum cytokines such as CRP, IL-6, ferritin at each time point

Chongqing Precision Biotech Co., Ltd

Paclitaxel

Albumin-Bound Paclitaxel

Enrolled participants will be given a preconditioning regimen consisted of albumin-bound paclitaxel, cyclophosphamide and fludarabine before the infusion of CD70-CAR-T cells.

Enrolled patients in this arm will be administered CD70-CAR-T cells in 3+3 based escalation manner.

Dose escalation:

Dose1 (1×10\^6 cells/kg) , Dose 2(3×10\^6 cells/kg) ,Dose 3 (1×10\^7cells/kg);

Dose expansion: RP2D

Drug: Albumin-bound paclitaxel

Administered intravenously at dose of 100-200mg/m2 on day -5;

Drug: Cyclophosphamide

Administered intravenously at dose of 15-30mg/kg on day -3 and day -2;

Drug: Fludarabine

Administered intravenously at dose of 30mg/m2 on day -3 and day -2;

CD70-targeting CAR-T cells

Weidong Han, Ph.D

Yang Liu, M.D

Yangbin Zhao, Ph.D

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 advanced/metastatic solid tumors . 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).

Currently, CAR-T cell therapy has already achieved tremendous success in the treatment of hematological malignancies,however, it remains a severe challenge to treat solid tumors due to multiple obstacles,such as absence of tumor specific antigens, complex immunosuppressive tumor microenvironment, and tumor heterogeneity.

CD70 is a member of the tumor factor superfamily and has been found to be highly expressed on the surface of several solid and hematological tumors, correlating with inferior prognosis.Targeting CD70 has emerged as potential novel immunotherapeutic strategy. Investigators have developed CD70-CAR-T cells that could effectively expand and survive，producing strong anti-tumor effects in animal models. 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.

CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors

Phase I/II Study of CD70 Targeted CAR-T Cell Treatment in CD70 Positive Advanced/Metastatic Solid Tumors

AE is defined as any adverse medical event from the date of randomization to 12 months after CD70-CAR-T cell infusion. Among them, CRS and ICANS were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.

DLT was defined as CD70-CAR-T cells-related events with onset within first 28 days following infusion: The development of Grade (G) 3 or higher grade CRS lasting \> 2 weeks; All G4 non-hematologic toxicities.

MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.

Number and copy number of CD70-CAR-T cells are evaluated by number in peripheral blood and tumor tissue.

Objective response rate includes complete response and partial response defined by investigators according to RECIST 1.1or iRECIST criteria.

Progression Free Survival is defined as the time from the initiation of CD70-CAR-T cell therapy to documented disease progression or death.

Time to response is defined as the time from the initiation of CD70-CAR-T cell therapy to first assessed CR or PR by investigators according to RECIST 1.1or iRECIST criteria.

Duration of response is defined as the time from objective response until documented tumor progression among responders.

Overall Survival is defined as the time from the initiation of CD70-CAR-T cell therapy to documented disease progression or death.

The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α), C reactive protein (CRP), ferritin. Peak was defined as the maximum post-baseline level of the cytokine.

UTC Therapeutics Inc.

Chinese PLA General Hospital

Director of Biotherapeutic Department

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Lymphosarcoma

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Each subject receive CD70 CAR T-cells by intravenous infusion

CD70 CAR T-cells

He Huang, PhD

Yongxian Hu, PhD

He Huang, MD

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases

This is a single arm, open-label, single-center study. This study is indicated for CD 70 CAR T for patients with CD70 positive malignant hematologic diseases. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 108 patients will be enrolled. Primary objective is to explore the safety,main consideration is dose-related safety.

CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24

From the first infusion of CD70 CAR-T cells to death or the last visit

From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse,

From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse

Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

Assessment using Activities of Daily Living (ADL) scale (Barthel Index) \[max score: 100, min score: 0, higher scores mean a better outcome\] at Baseline, Month 1, 3, 6, 9 and 12

Assessment of Instrumental Activities of Daily Living (IADL) scale \[max score: 56, min score: 14, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12

Assessment using Hospital Anxiety and Depression Scale (HADS) \[max score: 42, min score: 0, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12

Yake Biotechnology Ltd.

Zhejiang University

Clinical Professor

Cicatrix

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-Cell

Chronic Lymphocytic Leukemia

Patients who have relapsed and refractory B cell malignancies after chemotherapy will be treated with CD19 and CD20/CD22/CD30/CD38/CD70/CD123-specific gene-engineered T cells.

4SCAR19 and 4SCAR22

4SCAR19 and 4SCAR38

4SCAR19 and 4SCAR20

4SCAR19 and 4SCAR123

4SCAR19 and 4SCAR70

4SCAR19 and 4SCAR30

Lung-Ji Chang, PhD

Yuhua Li, M.D, Ph.D

Lihua Yang, M.D., Ph.D.

Xun Lai, MD

The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Background:

T cells modified with lentiviral chimeric antigen receptor (CAR) gene have been studied in different clinical settings. Recent successes suggest that increased costimulatory signaling in the CAR design is critical for long term efficacy. Several clinical reports indicate that many patients still relapse and developed CD19-negative cancer cells after CD19 targeted therapy. Thus, to prevent the target escapes and improve the therapeutic effects, CAR gene-modified T cells targeting CD20, CD22, CD30, CD38, CD70 or CD123 are considered to apply together with CD19 CAR-T cells.

Activation of T cell response to high tumor burden may induce a severe response. To increase safety, a novel design using an inducible caspase 9 fusion gene has been incorporated in the CAR gene. A 4th generation CAR lentiviral vector (4SCAR) carrying multiple costimulatory signals for CD28/CD137/CD27 plus an inducible apoptotic caspase 9 gene has been established. This study aims to evaluate the activities of a combination of CAR gene-modified T cells to target cancer cells based on specific CD19/CD20/CD22/CD30/CD38/CD70/CD123 single chain antibody gene designs (4SCAR19/20/22/30/38/70/123).

Objective:

To evaluate safety and efficacy of administrating 4SCAR19, 4SCAR20, 4SCAR22, 4SCAR30, 4SCAR38, 4SCAR70 and 4SCAR123 T cells to patients with mixed CD19 positive and negative B cell malignancies following a cyclophosphamide/fludarabine based conditioning regimen.

Eligibility:

Patients older than 6-month-old with CD19 positive or negative B cell malignancies that have recurred after or refractory to standard therapy and is deemed incurable using standard treatment.

Design:

Participants will be screened based on cancer cell phenotype analyzed using flow cytometry or immunohistochemical staining methods. Peripheral blood mononuclear cells (PBMC) will be obtained through apheresis. On Day -5 to -7, T cells from PBMC will be activated and enriched, which will be followed by 4SCAR19, 4SCAR20, 4SCAR22, 4SCAR30, 4SCAR38, 4SCAR70 and 4SCAR123 lentiviral transduction. The total cell preparation time is approximately 5-7 days. Participants will receive a preparative conditioning regimen comprising cyclophosphamide/fludarabine to prepare their immune system to accommodate the modified CAR T cells. The preparative regimen will depend on the immune condition of patients, which is consistent with standard chemotherapy conditioning regimen. Participants will receive an infusion of the modified 4SCAR19 and 4SCAR20/22/30/38/70/123 T cells and closely followed up for treatment-related responses. Participants will be continuously monitored for CAR T cells and clinical responses in a preset timeline.

Combination CAR-T Cell Therapy Targeting Hematological Malignancies

Combination CAR-T Therapy of 4SCAR19 Plus 4SCAR20, 22, 38, 70 and 123 Targeting Hematological Malignancies

physiological parameter (for safety, measuring cytokine response, fever, symptoms)

scale of CAR copies and leukemic cell burden (for efficacy)

Shenzhen Geno-Immune Medical Institute

President

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Infusion of CD70-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg

After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically

After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally

Fei Li, M.D

Fei Li, MD

This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic solid tumors, and obtain recommended doses and infusion patterns.

The research designs to follow 2 groups：Intravenous infusion group and Intraperitoneal injection group；each group sets up 2 phases,the first phase is dose discovery phase to obtain recommended doses,the second phase is dose expansion phase to verify the safety in the recommended doses. In the discovery phase,each group puts up 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.In the dose expansion phase,each group will choose one or two dose groups to verify the safety and efficacy at this dose,and plan to recruit about 6 subjects in each dose group.

A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

Disease control rate: The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.

Objective response rate includes：The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.

Concentration levels of CAR-T-related serum cytokines such as CRP, IL-6, ferritin at each time point，which measured by Chemiluminescence method

The First Affiliated Hospital of Nanchang University

Guantai Ni, M.D

Guantai Ni, MD

This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic Gynecologic Cancer, and obtain recommended doses and infusion patterns.

A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer

A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study of CD70-targeted CAR-T Therapy for Advanced/Advanced Renal Cancer	NCT05420519	Metastatic Tumo... Renal Cell Carc... Advanced Cancer	CD70 CAR-T cell...	18 Years -	Chongqing Precision Biotech Co., Ltd
CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors	NCT05947487	Solid Tumor, Ad...	CD70-targeting ...	18 Years - 75 Years	Chinese PLA General Hospital
Clinical Study of CD70-targeted CAR-T Therapy for Advanced/Advanced Renal Cancer	NCT05420519	Metastatic Tumo... Renal Cell Carc... Advanced Cancer	CD70 CAR-T cell...	18 Years -	Chongqing Precision Biotech Co., Ltd
CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases	NCT04662294	Acute Myeloid L... Non-hodgkin's L... Multiple Myelom...	CD70 CAR T-cell...	-	Zhejiang University
Combination CAR-T Cell Therapy Targeting Hematological Malignancies	NCT03125577	B-cell Malignan...	4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC...	6 Months - 75 Years	Shenzhen Geno-Immune Medical Institute
CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors	NCT05947487	Solid Tumor, Ad...	CD70-targeting ...	18 Years - 75 Years	Chinese PLA General Hospital
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors	NCT06010875	Renal Cell Carc... Ovarian Cancer Cervix Cancer Metastatic Canc... Advanced Cancer	CD70 CAR-T cell... CD70 CAR-T cell...	18 Years -	Chongqing Precision Biotech Co., Ltd
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer	NCT06215950	Ovarian Cancer Cervix Cancer Metastatic Canc... Advanced Cancer Gynecologic Can...	CD70 CAR-T cell... CD70 CAR-T cell...	18 Years -	Chongqing Precision Biotech Co., Ltd
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer	NCT06215950	Ovarian Cancer Cervix Cancer Metastatic Canc... Advanced Cancer Gynecologic Can...	CD70 CAR-T cell... CD70 CAR-T cell...	18 Years -	Chongqing Precision Biotech Co., Ltd
A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors	NCT06010875	Renal Cell Carc... Ovarian Cancer Cervix Cancer Metastatic Canc... Advanced Cancer	CD70 CAR-T cell... CD70 CAR-T cell...	18 Years -	Chongqing Precision Biotech Co., Ltd

Spots Global Cancer Trial Database for cd70

Every month we try and update this database with for cd70 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cd70

Every month we try and update this database with for cd70 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cd70 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.