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

ConditionColorectal Cancer (CRC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Immunochina Medical Science & Technology Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The age is 18 to 75 years (including boundary values) and the gender is not limited;

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;

Hemoglobin (Hb) ≥ 90 g/L;

Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10^9/L;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • IM96 CAR-T Cells

    Biological/Vaccine

    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.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: IM96 CAR-T CellsExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Up to 28 days after CAR-T cell infusion

Secondary outcomes

1

Objective remission rate (ORR)

Objective remission rate (ORR) after infusion

Time frame
At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion
2

Progression-free survival (PFS)

Progression-free survival (PFS) after infusion

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

Disease control rate (DCR)

Disease control rate (DCR) after infusion

Time frame
At 28 days, 3 months, 6 months and 12 months after CAR-T cell infusion
4

Duration of response (DOR)

Duration of response (DOR) after infusion

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Immunochina Medical Science & Technology Co., Ltd.

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Source ClinicalTrials.gov
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