What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include targeted therapies and immunotherapies. Targeted therapies, such as those aimed at the MUC1C protein, often involve monoclonal antibodies or small molecules that specifically target cancer cells. Known side effects of these treatments can include fatigue, skin reactions, diarrhea, and hypertension. Immunotherapies, such as checkpoint inhibitors, can cause immune-related adverse events like colitis, pneumonitis, hepatitis, and endocrinopathies. Both treatment types aim to minimize damage to normal cells but can still result in significant side effects that require careful management.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for colorectal cancer. Notable approvals include cetuximab and panitumumab, which target the epidermal growth factor receptor (EGFR), and bevacizumab, which inhibits vascular endothelial growth factor (VEGF). Additionally, pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, have been approved for colorectal cancers with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These treatments focus on specific molecular targets and pathways, similar to the investigational P-MUC1C-ALLO1 therapy aimed at the MUC1C protein overexpressed in epithelial-derived tumors.

What other types of research exist?

Promising novel alternatives to P-MUC1C-ALLO1 for colorectal cancer patients include: 1) Pembrolizumab for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). 2) Nivolumab, another PD-1 inhibitor, for MSI-H or dMMR tumors. 3) Combination therapies such as Nivolumab plus Ipilimumab for MSI-H or dMMR tumors. 4) Targeted therapies like Encorafenib combined with Cetuximab for BRAF V600E-mutant metastatic colorectal cancer. These therapies have shown efficacy in clinical trials and are considered promising options for colorectal cancer treatment.

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CAR T-cell Therapy

Allogeneic CAR-T Cells for Cancer

Phase 1

Recruiting

Research Sponsored by Poseida Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have progressed during or after last therapy and have measurable disease

Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70%

Must not have

Has a history of known genetic predisposition to HLH/MAS

Has a history of significant liver disease or active liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy using modified immune cells in adults with advanced cancers. The treatment aims to target and destroy cancer cells with a specific marker found in various cancers, including breast cancer.

Who is the study for?

Adults with advanced or metastatic solid tumors from a variety of cancers, who have not responded to standard treatments. Participants must be willing to use birth control, have good organ function, and an ECOG performance status of 0-1. They cannot join if they have significant CNS disease, active infections, recent corticosteroid therapy, other malignancies (except low-risk skin cancer), autoimmune diseases, severe heart issues or psychiatric disorders that affect protocol adherence.

What is being tested?

The trial is testing P-MUC1C-ALLO1 CAR-T cells combined with Rimiducid in adults with certain types of advanced cancers. It's a Phase 1 study which means it's early in the clinical trials process and focuses on finding the right dose while checking for safety.

What are the potential side effects?

Potential side effects may include immune system reactions due to CAR-T cell therapy such as fever and flu-like symptoms; possible infusion-related reactions; changes in blood counts leading to increased infection risk; fatigue; and organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has grown or spread after my last treatment and can be measured.

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I am mostly active and can care for myself.

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My cancer cannot be surgically removed, has spread, and does not respond to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic predisposition to HLH/MAS.

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I have a history of serious liver problems.

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I have taken or will need immunosuppressive drugs recently or during the study.

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I have cancer that has spread to my brain.

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I currently have an active infection.

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I have had a serious brain condition like a stroke or epilepsy.

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I have severe heart issues, including heart failure or a recent heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1

Phosphorus

Evaluate the preliminary efficacy of P-MUC1C-ALLO1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm M)Experimental Treatment2 Interventions

* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.

Group II: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm E)Experimental Treatment2 Interventions

* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.

Group III: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C)Experimental Treatment2 Interventions

* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated.

Group IV: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A1)Experimental Treatment2 Interventions

* Single ascending A1 dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.

Group V: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)Experimental Treatment2 Interventions

* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.

Group VI: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm F)Experimental Treatment2 Interventions

* Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.

Group VII: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)Experimental Treatment2 Interventions

* Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated.

Group VIII: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)Experimental Treatment2 Interventions

* Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

Not yet FDA approved

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, targeted therapies, and immunotherapies. Chemotherapy, such as FOLFOX (oxaliplatin, leucovorin, and fluorouracil), works by killing rapidly dividing cancer cells. Targeted therapies, like cetuximab, inhibit specific proteins such as the epidermal growth factor receptor (EGFR) in tumors with wild-type RAS genes, blocking cell proliferation. Immunotherapies, including CAR-T cells like those in the P-MUC1C-ALLO1 trial, target proteins like MUC1C that are overexpressed in cancer cells, enhancing the immune system's ability to recognize and destroy these cells. These treatments are crucial as they offer more personalized and effective options, potentially improving outcomes and reducing side effects for colorectal cancer patients.

An Insight Into the Driver Mutations and Molecular Mechanisms Underlying Mucinous Adenocarcinoma of the Rectum.Mucin glycoproteins block apoptosis; promote invasion, proliferation, and migration; and cause chemoresistance through diverse pathways in epithelial cancers.Abrogation of MUC5AC Expression Contributes to the Apoptosis and Cell Cycle Arrest of Colon Cancer Cells.