Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer

NCT06718738 | Recruiting Phase 1

• 1 other identifier: YMSZ9601
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced colorectal cancer

Conditions

Colorectal Cancer (CRC)

Keywords

Advanced colorectal cancer; IM96 CAR-T

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Related adverse events (AEs)

  Incidence of adverse events associated with IM96 CAR-T cell infusion within 28 days of IM96 CAR-T cell infusion, type, frequency, and severity of abnormal clinically significant vital signs, electrocardiograms, and laboratory tests examined, including dose-limiting toxicity

  Up to 28 days after CAR-T cell infusion

Secondary Outcomes (10)

• Objective remission rate (ORR)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Progression-free survival (PFS)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Disease control rate (DCR)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Duration of response (DOR)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

• Overall survival (OS)

  At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion

Study Arms (1)

IM96 CAR-T Cells

EXPERIMENTAL

After preconditioning with chemotherapy, IM96 CAR-T Cells will be evaluated

Biological: IM96 CAR-T Cells

Interventions

IM96 CAR-T Cells BIOLOGICAL

IM96 CAR-T Cells, 12×10\^8 CAR-T cells, 20×10\^8 CAR-T cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D- 3), determined by tumor burden at baseline. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.

IM96 CAR-T Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age is 18 to 75 years (including boundary values) and the gender is not limited;
• Patients with advanced GI tumors diagnosed by pathohistology, mainly:
• (1)Patients with metastatic colorectal cancer who have failed or are intolerant to second-line and above standard therapy;
• Notes:
• The standardized systemic treatment received by the patient must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Colorectal and Gastric Cancer, 2024 Edition;
• Claims of treatment intolerance: Patients who are unable to continue current effective systemic standardized treatment due to toxic side effects such as grade ≥3 vomiting, diarrhea, abdominal pain, bone marrow suppression, etc., and who do not accept refusal for financial and personal reasons; 3.Presence of at least one measurable lesion that meets RECIST 1.1 criteria; 4.Patients must provide a tumor sample within 2 years that meets the requirements (paraffin block or number of unstained sections that meet the testing requirements set by the Institute) that is positive for GUCY2C expression by immunohistochemistry; 5.Survival is expected to be more than 3 months; 6.Eastern cooperative oncology group (ECOG) score of 0-1 (refer to Attachment 2); 7.Women of childbearing potential who have a negative blood pregnancy test prior to the start of the trial and who agree to use effective contraception during the trial and up to the last follow-up visit; male patients whose partners are of childbearing potential agree to use effective contraception during the trial and up to the last follow-up visit 8.Laboratory tests should meet at least the indicators specified below:
• Hemoglobin (Hb) ≥ 90 g/L;
• Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10\^9/L;
• Platelet count (PLT) ≥ 75 x 10\^9/L;
• Absolute lymphocyte value ≥ 0.6 x 10\^9/L;
• Lymphocytes make up ≥10% of white blood cells;
• Creatinine clearance ≥60 ml/min;
• Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN and total bilirubin (TBL) ≤ 1.5 x ULN (for elevations of ALT and AST that can be explained by hepatic aggression, the high limits for AST and ALT can be adjusted upward to 5-fold, and the high limit for TBL may be adjusted upward to 3-fold;
• Serum albumin ≥ 3.0 g/dL.
• Prolongation of prothrombinogen time ≤ 4s; 9.Left ventricular ejection fraction ≥ 50% with a normal ECG or an abnormal ECG that, in the judgment of the investigator, does not require treatment; 10.Oxygen saturation \>92% in non-oxygenated state; 11.Vascular access is adequate for cell collection, and lines are available for patients with existing central venous catheters; Those who voluntarily participate in the trial and sign the informed consent form

You may not qualify if:

• Presence of brain metastases;
• Patients who have previously received or are awaiting an organ transplant;
• Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);
• Plasmapheresis (e.g., pleural effusion, abdominal effusion, pericardial effusion) with symptoms of compression that cannot be controlled with treatment;
• Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;
• Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test abnormalities;
• Use of any of the following medications or treatments during the designated time period prior to cell collection:
• Therapeutic doses of corticosteroids have been used within 7 days prior to cell collection. However, topical and inhaled steroids are permitted;
• Received chemotherapeutic agents within 1 week prior to cell collection. Enrollment was allowed if the oral chemotherapeutic drug had passed at least 3 half-lives prior to cell collection;
• Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;
• Use of study drug within 4 weeks prior to cell collection. However, enrollment was allowed if the trial treatment was ineffective or the disease progressed during the trial and at least 5 half-lives had elapsed prior to cell collection;
• Received interventional therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection;
• Patients who have had major surgery or significant trauma within 4 weeks prior to cell collection or who are expected to require major surgery during the study period;
• Received treatment with targeted agents such as regorafenib, furaquintinib, etc. within 1 week prior to cell collection;
• Prior treatment with anti-GUCY2C target (unless GUCY2C target test remains positive);

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lin Shen, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu

CONTACT

8615801390058; wufei@imunopharm.com

Lin Shen, PhD

CONTACT

8610 88196561; doctorshenlin@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 15, 2024
• Primary Completion: August 15, 2025
• Study Completion (Estimated): August 15, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)