Health TrialsbyHealthPanel

KSH01-R02-101 Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRx Therapeutics Co.Ltd

About this trial

1. . safety and tolerance 2. . objective response rate

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Voluntary participation in clinical research; Fully understand the study and voluntarily sign the informed consent form; Willing to follow and able to complete all test procedures;

2) Male or female, 18 to 70 years old (including boundary value);

3) Malignant solid tumors failed to receive standard treatment;

4) HLA-A * 02 is positive and tumor target is positive (the staining intensity of target tumor cells is divided into 0, 1+, 2+, 3+, and more than 30% of cancer cells express 2+or 3+positive as the target is positive)

Disqualifiers

6.1.1) Neutrophil count (ANC) is not lower than the lower limit of normal value of the center;

6.1.2) White blood cell (WBC) shall not be lower than the lower limit of normal value of the center;

6.1.3) Platelet count (PLT) shall not be lower than the lower limit of normal value of the center;

6.1.4) Hemoglobin (Hb) shall not be lower than 0.8 * LLN (lower limit of normal value);

Trial design

Design model

Single group

Treatments tested in this trial

  • KSH01 injection

    Drug

    TCR-T cell injection

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: TCR-T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants in treatment related adverse events assessed by CTCAE v4.0

To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor subjects.

Time frame
about 3 years
2

objective remission rate

To preliminarily evaluate the objective remission rate of autologous TCR-T cells in the treatment of target positive solid tumor subjects (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.).

Time frame
about 3 years

Secondary outcomes

1

Maximum tolerable dose values

Maximum tolerable dose values

Time frame
about 3 years
2

Changes in tumor size and time.

Preliminary evaluation of anti-tumor efficacy of autologous TCR-T cells in solid tumor subjects

Time frame
about 5 years
3

Concentration of pharmacokinetic values in plasma

To evaluate the pharmacokinetics of autologous TCR-T cells in solid tumor subjects

Time frame
about 3 years
4

Concentration of cytokine level value in plasma

To evaluate the cytokine level of autologous TCR-T cells in solid tumor patients during treatment

Time frame
about 3 years

Other outcomes

Sponsors and contacts

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

TCRx Therapeutics Co.Ltd

Lead sponsor

Source ClinicalTrials.gov
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