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CAR T-cell Therapy

Allogeneic CAR-T Cell Therapy for B-Cell 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 15 years

Awards & highlights

Study Summary

This trial tested a new treatment for advanced B cell cancers using cells from a donor's immune system.

Who is the study for?

Adults (≥18 years) with certain B cell malignancies like DLBCL, FL, MCL, MZL, PMBCL or CLL that have relapsed or are not responding to treatment. They must have tried specific therapies and meet health criteria including organ function and blood counts. Pregnant individuals, those with autoimmune diseases or active infections are excluded.Check my eligibility

What is being tested?

The trial is testing P-CD19CD20-ALLO1 allogeneic CAR-T cells along with Rimiducid in patients with B cell cancers that came back or didn't respond after treatment. It's a Phase 1 study where doses will be increased gradually to find the safest dose that works.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related symptoms such as fever and chills, fatigue, changes in blood counts leading to increased infection risk, and possible impact on normal organ functions.

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

To assess the safety and MTD of P-CD19CD20-ALLO1 based on dose limiting toxicities (DLT)

Secondary outcome measures

The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (DOR)

The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (ORR)

The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (OS)

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: P-CD19CD20-ALLO1 CAR-T Cells (Arm S)Experimental Treatment2 Interventions

P-CD19CD20-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered.

Group II: P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 750)Experimental Treatment2 Interventions

P-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 750. Rimiducid may be administered.

Group III: P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 1000)Experimental Treatment2 Interventions

P-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 1000. Rimiducid may be administered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

2019

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roche-GenentechIndustry Sponsor

24 Previous Clinical Trials

3,585 Total Patients Enrolled

Poseida Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

596 Total Patients Enrolled

Rajesh Belani, MDStudy DirectorVice President, Clinical Development

Frequently Asked Questions

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

Has the FDA given authorization to P-CD19CD20-ALLO1 CAR-T Cells?

"Due to the limited clinical data available for its safety and efficacy, we have given P-CD19CD20-ALLO1 CAR-T Cells a score of 1."

Answered by AI

Are there any establishments in North America currently conducting this experiment?

"Patient recruitment is currently being conducted at the Wayne State - Karmanos Cancer Institute in Detroit, Michigan; UNC Lineberger Comprehensive Cancer Center in Chapel Hill, North carolina; University of Cincinnati in Cincinnati, Ohio and 8 other centres."

Answered by AI

Are there any opportunities for participants to join this research study presently?

"According to clinicaltrials.gov, this trial is presently not recruiting participants as its last update was on August 25th 2023. However, there are 1,935 other trials actively enrolling patients today."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies

2024. "P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014762.

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