Clinical trial · Interventional

TIL Cells for the Treatment of the Advanced Solid Tumors Patients

A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy

NCT05649618CI-TRIAL-00062675unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Solid Tumor	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Cyclophosphamide Capsules	Drug	Cyclophosphamide	ALIAS
Fludarabine	Drug	Fludarabine	ALIAS
IL-2	Drug	—	UNRESOLVED
Tumor Infiltrating Lymphocytes	Biological	Therapeutic Tumor Infiltrating Lymphocytes	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Tumor Infiltrating Lymphocytes
description
TIL cells (2.5×10\^9-5×10\^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.
interventionNames
1. Biological: Tumor Infiltrating Lymphocytes
2. Drug: Fludarabine
3. Drug: Cyclophosphamide Capsules
4. Drug: IL-2

Primary outcomes (2)

measure
Dose Limiting Toxicity
timeFrame
up to Day 28
description
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TILs therapy.
measure
Adverse Event
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
2. 18 \~ 75 years;
3. The expected survival period is at least 3 months;
4. ECOG score of 0-1;
5. There is at least one lesion that can be operated or biopsied for the preparation of TIL;
6. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
7. Patients with recurrent or metastatic solid tumors confirmed by histopathology;
8. Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline ;
2. Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
3. Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;
4. Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;
5. Patients who have received adoptive cell therapy in the past;
6. According to the judgment of the investigator, the condition of the subject is not suitable for this trial.

References

Publications (0)

Data not yet available

No reference posted for this study.