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Phase Ib Clinical Study on the Safety, the Tolerability, the Pharmacokinetics and the Efficacy of ScTIL Injection (Gene Modified Tumor Infiltrating Lymphocytes) Alone and in Combination With B Lymphocyte Adjuvant in the Treatment of Digestive System Malignant Solid Tumors

NCT05730361 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-02-15

No results posted yet for this study

Summary

This is an open-lable, single-arm, single-dose escalation and multiple-dose extention clinical study of cell therapy designed to observe and evaluate the tolerance, the pharmacokinetic characteristics, the safety and the efficacy of ScTIL210 injection alone and in combination with B lymphocytes adjuvant in the treatment of digestive system malignant solid tumors.

Conditions

  • Digestive System Malignant Solid Tumors

Interventions

BIOLOGICAL

ScTIL injection

Peripheral blood mononuclear cells (PBMCs) obtained via apheresis are used for cell preparation. PD-1 positive T cells are isolated from PBMCs, are transduced with lentivirus loaded with "enhanced receptor" and "superamplification factor", and cell number are amplified. The obtained ScTIL is used for one-time intravenous infusion.

BIOLOGICAL

ScTIL injection and B lymphocytes adjuvant

B lymphocyte are also isolated from PBMCs. If the percentage of subject's B lymphocyte in total lymphocytes is \> 5%, the autologous B lymphocyte adjuvant will be prepared. If this percentage is ≤ 5%, PBMCs will be collected from haploidentical donor of the subject via apheresis, and B lymphocyte will be isolated for preparation of allogeneic B lymphocyte adjuvant.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen, Prof. Dr. · Locations: Beijing University Cancer Hospital, Beijing, China, 100142

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-05-31
Completion
2024-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05730361 on ClinicalTrials.gov