Health TrialsbyHealthPanel

HS-IT201 Injection in the Treatment of Advanced Solid Tumors

ConditionSolid Tumor
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQingdao Sino-Cell Biomedicine Co., Ltd.

About this trial

Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT201) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 years to 75 years at the time of consent;

Diagnosis by cytology or histology, failure to standard treatment (including disease progression and/or adverse reactions are not tolerated) or are judged by the investigator to be unsuitable for the use of existing standards Treatment methods for patients with advanced solid tumors, including but not limited to kidney cancer, non-small cells Lung cancer, stomach cancer, colorectal cancer, melanoma, etc. Participants are required to have a minimum of menstruation Through first-line treatment.

At least one resectable lesion that has not received radiotherapy or other local therapy within 28 days, and the weight of the tissue must be ≥ 0.050g；or resectable lesions capable of producing sufficient TIL;

At least one measurable target lesion, as defined by RECIST v1.1，that has not received radiotherapy or other local therapy unless these therapies occurred 28 days ago and target lesion shows significant progression;

Disqualifiers

Test subjects who have a history of hypersensitivity to any component or excipient of HS-IT101 or other study drugs (cyclophosphamide, fludarabine and recombinant human interleukin-2);

Test subjects who have active major medical illnesse(es) of the cardiovascular (within 6 months prior to enrollment), including deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient cerebral ischemia Seizures, cerebral embolism;

Active autoimmune diseases that require systemic treatment during the study period (eczema, vitiligo, psoriasis, alopecia or Grave's disease that do not require systematic treatment in the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes subjects that only require insulin replacement therapy can be included);

Organ transplantation and a history of hematopoietic stem cell transplantation;

Trial design

Design model

Single group

Treatments tested in this trial

  • HS-IT201 Injection

    Drug

    Adoptive transfer of 5x10\^9-4x10\^10 autologous TIL to patients i.v. in 30-60 minutes.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: HS-IT201 monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AE)

To characterize the safety profile of HS-IT201 in patients with advanced solid tumor as assessed by incidence of adverse events

Time frame
12 months
2

Serious Adverse Events (SAE)

To characterize the safety profile of HS-IT201 in patients with advanced solid tumor as assessed by incidence of serious adverse events

Time frame
12 months

Secondary outcomes

1

Objective Response Rate (ORR)

Committee (IRC) per RECIST v1.1

Time frame
Up to 36 months
2

Time-to-response (TTR)

To evaluate the efficacy of HS-IT201 in patients with advanced solid tumor by assessing the time-to-response (TTR) as assessed by the Investigator per RECIST v1.1

Time frame
Up to 36 months
3

Duration of Response (DOR)

To evaluate the efficacy of HS-IT201 in patients with advanced solid tumor by assessing the duration of response (DOR) as assessed by the Investigator per RECIST v1.1

Time frame
Up to 36 months
4

Disease Control Rate (DCR)

To evaluate the efficacy of HS-IT201 in patients with advanced solid tumor, based on the disease control rate (DCR) as assessed by the Independent Review Committee (IRC) per RECIST v1.1

Time frame
Up to 36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Qingdao Sino-Cell Biomedicine Co., Ltd.

Lead sponsor

The Affiliated Hospital of Qingdao University

Collaborator

Source ClinicalTrials.gov

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