Early Phase 1 Colorectal Cancer Trial, Recruiting NCT06446050 Sponsor: Shanghai East Hospital Condition: Colorectal Cancer
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Early Phase 1 Colorectal Cancer Trial, Recruiting

NCT06446050
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 years old or younger, of any gender
  • People diagnosed with colorectal cancer that has spread to other parts of the body or has grown into nearby tissues, confirmed by a tissue or cell sample test
  • People whose cancer can be measured on scans according to standard medical guidelines (RECIST version 1.1)
  • People whose cancer has gotten worse despite standard treatments, who could not tolerate standard treatments, or who have chosen not to have standard treatment
  • People whose blood counts and organ function results fall within the ranges required by the trial (covering blood cell levels, liver and kidney function, and blood clotting measures — confirm specific values with the trial site)
  • People with a general health/activity score of 0, 1, or 2 on the ECOG scale (meaning able to carry out at least some daily activities)
  • People who are able to have children and agree to use reliable contraception during the trial and for at least 12 weeks after the last treatment
  • People who have not had any other adoptive immune cell therapy or stem cell therapy in the past two years
  • People who are willing to take part and sign a written consent form

Who may not be able to join:

  • People with a known history of allergic reactions to biological medicines or to any substances used in cell culture processes
  • People who are pregnant or breastfeeding
  • People with an expected survival of more than 3 months (confirm with trial site, as this criterion is unclear)
  • People with an active infection that requires treatment throughout the body, or an infection that cannot be controlled
  • People who still have side effects from previous cancer treatments that have not recovered to a mild level (grade 1 or lower), except for hair loss
  • People with a history of serious heart or brain blood vessel conditions, including certain abnormal heart rhythms requiring medical intervention, a heart attack, heart failure, stroke, or other serious heart events within the past 6 months, significant heart function problems, or high blood pressure that remains poorly controlled despite treatment
  • People with serious lung or lung blood vessel conditions, including those considered at high risk for blood clots in the veins, or those who need extra oxygen to maintain normal blood oxygen levels
  • People with active or symptomatic cancer spread to the brain or the lining of the brain (people with stable brain spread may still be considered)
  • People with a clinically confirmed autoimmune disease, except for thyroid inflammation
  • People with HIV infection, or an active Epstein-Barr virus or cytomegalovirus infection
  • People with active hepatitis B virus replication or hepatitis C infection
  • People who have previously had a bone marrow transplant using donor cells
  • People with a known immune deficiency, or those who need to take steroid medications above a certain dose or other immune-suppressing medications within 14 days before starting the trial or during the trial period (some short-term or preventive steroid use may be excepted — confirm with trial site)
  • People with a known dependence on alcohol or drugs
  • People whom the trial doctor considers unsuitable for full participation due to any other medical history, condition, treatment, or test result

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Yong Gao, MD, Shanghai East Hospital

Phone: +86-18817821998

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Shanghai East Hospital
Registry
ClinicalTrials.gov
Start date
21 June 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose-Limiting Toxicities rate (DLT); Adverse Event (AE); Determination of optimal dose of MSC-L

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov