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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04627740
Other study ID # TCRCureALPPCART
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2023

Study information

Verified date November 2020
Source Xinqiao Hospital of Chongqing
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive metastatic ovarian and endometrial cancer.


Description:

Primary Objectives: To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells. Secondary Objectives: The number of patients experience objective response from anti-ALPP CAR-T cells treatment To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients. The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Expected to survive more than 3 months - PS 0-2 - Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%) - Patients with no curative regimen to receive - WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L - HBV DNA copy number less than 100/ml - ALT=5ULN, AST=5ULN, TB=1.5ULN, ALB=35g/L - Understand this test and have signed informed consent Exclusion Criteria: - Autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial - Decompensated liver cirrhosis, liver function Child-pugh C grade - Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous - Long-term use of immunosuppressive agents after organ transplantation - Screening indicated that the target cell transfection rate was less than 30% - Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization - Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization - Pregnant or lactating subjects - In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration - Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Retroviral vector-transduced autologous T cells to express anti-ALPP CARs
Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Xinqiao Hospital of Chongqing TCRCure Biopharma Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients suffering treatment-related AE To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells. 1 year
Secondary Objective response rate to ALPP-CART infusion The number of patients experience objective response from anti-ALPP CAR-T cells treatment Eight weeks
Secondary Progression-free survival to ALPP-CART infusion To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma. 6 months
Secondary Number of peripheral CAR-T after infusion The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion 6 months
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