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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

Males or females, Subjects ≥18 years with life expectancy >3 months

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 15 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment in adults with advanced or metastatic epithelial-derived solid tumors.

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.Check my eligibility

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.See study design

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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I am 18 or older and expected to live more than 3 months.

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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.

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I have recovered from side effects of previous treatments.

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My vital organs are functioning well.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: 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 conditioning chemotherapy regimen 2. Rimiducid may be administered as indicated.

Group II: 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 conditioning chemotherapy regimen 1. Rimiducid may be administered as indicated.

Group III: 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 conditioning chemotherapy regimen 2. Rimiducid may be administered as indicated.

Group IV: 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 conditioning chemotherapy 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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Poseida Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

596 Total Patients Enrolled

Rajesh Belani, M.D.Study DirectorSponsor Executive Medical Director

4 Previous Clinical Trials

496 Total Patients Enrolled

Media Library

P-MUC1C-ALLO1 CAR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05239143 — Phase 1

Colorectal Cancer Research Study Groups: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A), P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B), P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C), P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)

Colorectal Cancer Clinical Trial 2023: P-MUC1C-ALLO1 CAR-T cells Highlights & Side Effects. Trial Name: NCT05239143 — Phase 1

P-MUC1C-ALLO1 CAR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239143 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have registered for this medical experiment?

"Poseida Therapeutics, Inc., the entity responsible for this research project, must identify 100 individuals that meet the protocol's eligibility requirements. The trial will be conducted in multiple sites including MD Anderson Cancer Center (Houston, Texas) and University of California, San Francisco (San Francisco, California)."

Answered by AI

Are there any openings for this research endeavor at the present?

"According to clinicaltrials.gov, this medical trial is actively recruiting participants at the time of writing. The initial posting was on February 15th 2022 and it has been adjusted lastly on October 26th 2022."

Answered by AI

What regulatory approval has P-MUC1C-ALLO1 CAR-T cells obtained?

"Due to the limited amount of data corroborating its efficacy and safety, P-MUC1C-ALLO1 CAR-T cells has been ranked a 1 on our team's scale."

Answered by AI

What is the geographic distribution of this experiment?

"This medical study has opened enrolment at 5 distinct locations, including MD Anderson Cancer Center in Houston and NEXT Oncology in San Antonio. Additionally, there are 3 other sites participating such as University of California – San Francisco."

Answered by AI

Who else is applying?

What site did they apply to?

University of California, San Diego

What portion of applicants met pre-screening criteria?

Met criteria

What questions have other patients asked about this trial?

How long the study last? How often is treatment applied? Do I need to be hospitalized ?

PatientReceived 1 prior treatment

Why did patients apply to this trial?

I had two chemotherapy regimens without success, three surgeries of which none of the tumor could be resected. You are a light of hope for me and my family ( i have a five years old child)and I have read about cases of success in other types of cancer with this treatment and i feel that I am a perfect candidato for this trial. Thank you.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

2022. "P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05239143.

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