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Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors

ConditionsPeritoneal Carcinoma MetastaticPleural Effusion, MalignantHER2 Positive Malignancies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

CAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. In this study, the PD-L1 inhibitory signal was transformed into an activation signal in the tumor microenvironment, and enhanced the killing activity and survival ability of CAR-T cells. The HER-2/PD-L1 dual-targeting CAR-T will be investigated in patients with HER2-positive solid tumors, and all enrolled subjects will receive HER2/PD-L1 CAR T cells via intravenous or thoracic/peritoneal cavity infusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, Age 18-75 years old; If the subjects are over 75 years old, the researchers will determine whether to enroll according to the basic health conditions of the subjects, regardless of gender. No upper age limit was set for chest/abdominal reinfusion CAR-T subjects.

Estimated life expectancy ≥ 3 months (according to investigator's judgement);

The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;

Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, head and neck cancer, pancreatic cancer, colorectal cancer, transitional cell carcinoma, endometrial carcinoma, sarcoma, glioblastoma, cholangiocarcinoma, etc. have received standard systemic treatment, have systemic metastasis/serosal cavity metastasis or are not tolerated;

Disqualifiers

Allergic to cytokines;

Uncontrolled activity infection;

Acute or chronic (graft-versus-host disease) GVHD;

Accompanied by other uncontrolled malignant tumors;

Trial design

Design model

Single group

Treatments tested in this trial

  • Dual-targeting HER2 and PD-L1 CAR-T cells

    Biological/Vaccine

    HER2-positive solid tumor serosal cavity infusion

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: CAR-T cell therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Related Adverse Events

AE during the first 28 days after CAR-T cell administration

Time frame
12 months
2

Dose-limiting toxicity (DLT)

Baseline up to 28 days after CAR-T cells infusion

Time frame
12 months

Secondary outcomes

1

ORR（objective response rate）

Include CR（complete response）and PR（partial response）

Time frame
Month 1，month 3, month 6
2

DOR (duration of response)

The time from achievement of disease control

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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