Using immune cells to treat advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) injections in patients with advanced colorectal cancer who have not responded to first-line chemotherapy. It is a single-arm, open-label design that aims to assess the pharmacokinetics and efficacy of the treatment to determine the optimal biological dose. Participants will be monitored for their response to the therapy and overall health during the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
2. Age 18 to 70 years old;
3. Advanced Colorectal Cancer that progresses after first-line chemotherapy；
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Expected survival time of ≥ 12 weeks;
6. Good function of vital organs;
7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

1. Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
2. Known mental illness, alcoholism, drug use or substance abuse;
3. Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
4. Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
5. The investigators determine that other conditions that make the patient not suitable for enrollment

Where it's running

• Shanghai Jiaotong University School of Medcine, Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zheng Wang
• Email: wangzh1972@126.com
• Phone: 13501625681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GT719 injection for people with moderate to severe refractory autoimmune disease.

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• GT719 universal cell injection for adults with relapsed or refractory CD19-positive B-cell cancers

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  Recruiting Early Phase 1 Grit Biotechnology · Ganzhou, Jiangxi · NCT07131254

• GT719 injection for adults with moderate to severe refractory autoimmune diseases

  This trial will try giving GT719 injections to 10 adults with moderate to severe autoimmune diseases that haven't responded to standard treatments to see if the treatment is safe and helps control their disease.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.