Postoperative Adjuvant Therapy for CT041 Gastric or Gastr... | NCT06857786

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Phase 1b, open-label, single-arm trial	Experimental	Drug: CT041 autologous CAR T-cell injection	Drug: Drug: CT041 autologous CAR T-cell injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug: CT041 autologous CAR T-cell injection	Drug	The planned dose of satri-cel in this trial was 2.5 × 108 cells, single infusion. The trial will start with a safety run-in phase, which is defined from the day of infusion to the 28th day after infusion for the first 6 participants. The type, grade, incidence rate, and outcome of adverse events during the safety run-in phase will be summarized and assessed by the investigator and collaborator (CARsgen Therapeutics Co., Ltd). The investigator and collaborator could discuss and assess whether the lower or higher doses should be explored based on the based on the safety and tolerability, cellular metabolic characteristics, and benefit-risk profile. If no dose adjustment is required, satri-cel dose will continue to be 2.5 × 108 cells for the rest of the participants.

Measure	Description	Time Frame
Incidence, type, and severity of adverse events	ncidence, type, and severity of adverse events, including Adverse Events (AEs) Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs)	Signed ICF to 15 years after CT041 infusion

Measure	Description	Time Frame
Disease-free survival (M12-DFS)	Disease-free survival (M12-DFS) rate at 12 months after surgery	12 months after surgery
Disease-free survival (DFS) after surgery	Disease-free survival (DFS) after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Must have voluntarily signed the informed consent form (ICF) and be willing to comply with all trial procedures.

2. Must be 18 -75 years old (inclusive), male or female. 3. Pathologically confirmed diagnosis of gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.

4. Must have CLDN18.2-positive tumor expression as determined by immunohistochemistry (IHC), defined as CLDN18.2 staining intensity ≥ 1+ in at least 70% of tumor cells.

5. Must have undergone D2 gastrectomy and achieved R0 resection. 6. Must have pathological stage (y)pT4aN+ or (y)pT4bNany) according to the American Joint Committee on Cancer (AJCC) TNM Staging Classification (8th ed., 2017).

7. Must have received full cycles of standard adjuvant chemotherapy according to treatment guidelines. Standard adjuvant chemotherapy allowed in this trial includes FLOT(docetaxel + oxaliplatin + fluorouracil), CapeOX (oxaliplatin + capecitabine), and FOLFOX(oxaliplatin + fluorouracil).
1. Neoadjuvant chemotherapy is allowed.
2. Participants who are deemed intolerable or medically improper to complete the full cycles of adjuvant chemotherapy or not beneficial as determined by the investigator could be eligible after discussing with the medical monitor.
  
  8. Must have no evidence of recurrent or metastatic G/GEJ adenocarcinoma. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days before leukapheresis).
  
  10. Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis.
  
  11. Laboratory results within 7 days before leukapheresis must meet the following criteria (Retesting once within one week is permitted. it will be considered a screening failure if retest still not meets the criteria): 12. Women of childbearing potential (WOCBP) must undergo a serum pregnancy test with negative result at screening and must be willing to use effective and reliable method of contraception for at least 12 months after the last satri-cel infusion. Egg donation should be refrained for 12 months.
  
  13. Male part
  
  Exclusion Criteria:
1. The time interval between leukapheresis and completion of adjuvant chemotherapy is more than 12 weeks.
2. Participants with high risk of bleeding, perforation or obstruction, including but not limited to deep or large ulcer, unstable/active ulcer, active or history of digestive tract bleeding/perforation/obstruction within three months.
3. Participants who have received any non-standard adjuvant anti-tumor treatment for G/GEJ adenocarcinoma allowed in this trial, including any systemic anti-tumor drugs not specified in the protocol, any radiotherapy or interventional therapy, etc.
4. Participants who have received systemic anti-tumor treatment for G/GEJ adenocarcinoma within 2 weeks (or within 5 half-lives of the drug, whichever is shorter) prior to leukapheresis.
5. Participants who have received major surgery (excluding cataract surgery and others requiring local anesthesia) within 4 weeks prior to leukapheresis or significant traumatic injury and have not recovered adequately from the toxicity and/or complications. Participants who are anticipated to need major surgery during the trial will also be excluded.
6. Participants who have received any prior genetic engineering modified cellular therapy (such as CAR T-cell, TCR T-cell, etc.).
7. Participants with AEs from previous treatment who have not recovered to Grade ≤ 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, excluding hair loss, neuropathy, other events that are unlikely to cumulate toxicity from trial treatment as determined by the investigator, and laboratory abnormalities allowed in this trial.
8. Participants with serologically positive human immunodeficiency virus (HIV), Syphilis, and hepatitis C virus (HCV). HCV antibody positive but HCV RNA negative can be enrolled.