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SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer

ConditionsOvarian CancerFallopian Tube CarcinomaPeritoneal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShanghai Gynecologic Oncology Group

About this trial

This study is an open-label, dose-escalation, investigator-initiated phase I interventional clinical study. To evaluate the safety, tolerability and preliminary efficacy of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer, and to explore the pharmacokinetic characteristics, biomarker changes and immunogenicity of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer.

In this study, two trial cohorts were set up, cohort 1 was the intraperitoneal route of administration, and the subjects enrolled in cohort 1 needed to meet the conditions for intraperitoneal administration ((1) the subject had a large amount of ascites, (2) the subject was suitable for peritoneal catheterization, (3) the subject had no severe abdominal adhesions, and (4) the subject agreed to undergo intraperitoneal surgical catheterization for intraperitoneal administration); Cohort 2 is the intravenous route.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG performance status score: 0~2 points or KPS score≥70 points;

Relapsed or refractory epithelial ovarian, fallopian tube and peritoneal cancer confirmed by histology or cytology and have failed, are intolerant or have no standard treatment after standard therapy;

Tumor tissue specimens or tumor samples can be obtained by tumor biopsy and other methods;

Immunohistochemistry (IHC) staining confirmed that the tumor cells had positive TAG-72 expression (positive definition: >). IHC staining intensity of 1% tumor cells ≥2+);

Disqualifiers

Those who are allergic to any component of SCT-001 CAR-T cell injection;

Received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc., or participated in other clinical trials and received 5 half-lives of therapeutic drugs within 4 weeks prior to the first use of the study drug (4 weeks or 5 half-lives, whichever is shorter);

Received treatment with traditional Chinese medicine or modern Chinese medicine preparations with anti-tumor indications in the label within 14 days before the first dose;

The adverse reactions of previous anti-tumor therapy have not recovered to NCI CTCAE v5.0 grade evaluation ≤ grade 1 (except for toxicity that the investigator judges has no safety risk such as alopecia);

Trial design

Design model

Parallel

Treatments tested in this trial

  • SCT-001 CAR-T cells

    Biological/Vaccine

    SCT-001 CAR-T cells are autologous-derived CAR-T cell products, which transduce second-generation CAR targeting TAG-72 into patient autologous T cells by lentiviral transfection, and knock out immunosuppressive related genes by CRISPR/Cas9 technology to enhance the anti-tumor function of CAR-T cells.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: SCT-001 CAR-T intraperitoneal route of administrationExperimental treatment 1 intervention
Group B: SCT-001 CAR-T intravenous route of administrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (DLTs)

The incidence of of DLT event, which is defined as toxic events related to SCT-001 CAR-T cell injection that occur within the DLT observation period (28 days after CAR-T cell injection), including general adverse events graded according to NCI CTCAE v5.0, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS).

Time frame
28 days
2

Incidence of adverse events

Toxicity within 24 months after CAR-T cell injection will be graded according to the NCI CTCAE v5.0.

Time frame
24 months

Secondary outcomes

1

Change of CAR Copies

CAR Copies measured by qPCR (12 months after CAR-T infusion)

Time frame
12 months
2

Objective response rate

The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Gynecologic Oncology Group

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: