Not Yet RecruitingPhase 1

Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis

6 participantsStarted 2025-04

Plain-language summary

A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Signed informed consent
✓. Good physical condition (WHO performance status score 0-1).
✓. Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
✓. Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.
✓. The LENT-SOMA score was ≥1 during the screening period.
✓. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.

Exclusion criteria

✕. Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.
✕. Patients with allergic constitution or severe systemic autoimmune diseases.
✕. Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.
✕. Pregnant or lactating women.
✕. Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
✕. Patients with a LENT-SOMA score of 4 during the screening period.
✕. Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.
✕. Patients with uncontrolled tumors, tumor recurrence or metastasis.

What they're measuring

Radioactive distribution

Timeframe: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour

Trial details

NCT IDNCT06925607

SponsorJiangsu Topcel-KH Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Jueyu Xia, Master

025-52700103 xiajueyu@topcelbio.com

View on ClinicalTrials.gov More Radiation Proctitis trials