Health TrialsbyHealthPanel

Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors

ConditionAdvanced Solid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University

About this trial

A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily willing to participate in the study and sign the written informed consent form

Age ≥18 years and ≤75 years,male or female .

Human leukocyte antigen (HLA)-A*11:01 matched

Fresh or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry(IHC)-stained MAGE-A4 positive（+2，≥30%）

Disqualifiers

Pregnant or lactating women.

HIV, treponema pallidum or HCV serology is positive.

Patients with any uncontrolled active infection, including, but not limited to, active tuberculosis or HBV infection (HBsAg positive or HBV DNA positive).

Patients with symptomatic central nervous metastases.

Trial design

Design model

Single group

Treatments tested in this trial

  • YK1101 cells

    Biological/Vaccine

    Drug: Fludarabine + Cyclophosphamide

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: YK1101 cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Dose-limiting toxicity

Time frame
28 days
2

Treatment related AEs

Treatment related AEs

Time frame
28 days

Secondary outcomes

1

Antitumor efficacy-Objective response rate (ORR)

The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%).

Time frame
2 years
2

Antitumor efficacy-Progression-free survival (PFS)

The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.

Time frame
2 years
3

Antitumor efficacy-Overall survival (OS)

The period from the first infusion to any cause of death

Time frame
2 years
4

Antitumor efficacy-Duration of response (DOR)

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Peking University

Lead sponsor

Yingkai Saiwei（Beijing）Biotechnology Co., Ltd

Collaborator

Source ClinicalTrials.gov
Apply now