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CAR T-cell Therapy

BPX-501 + Rimiducid for Leukemia

Phase 1

Waitlist Available

Research Sponsored by Bellicum Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of one of the following adult hematological malignancies: Leukemia, Myelodysplastic Syndromes, Lymphomas, Multiple myeloma, Other high-risk hematologic malignancies eligible for stem cell transplantation per institutional standard

Performance status: Karnofsky score > 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 24

Awards & highlights

Study Summary

This trial is investigating a new treatment for leukemia consisting of infusions of BPX-501 T cells, with the goal of finding a dose that is effective against the disease while also mitigating side effects.

Who is the study for?

Adults aged 18-65 with certain blood cancers like leukemia, lymphoma, or myeloma who've had a stem cell transplant but are seeing their cancer return. They need to be relatively healthy otherwise, with good heart, liver, kidney and lung function and no severe complications from the transplant.Check my eligibility

What is being tested?

The trial is testing BPX-501 T cells given in increasing doses to see if they can fight the cancer after a stem cell transplant. It's also looking at Rimiducid's ability to control graft versus host disease without hurting the anti-cancer effects of the T cells.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to infused T cells or symptoms related to graft versus host disease management. Specific side effect profiles for BPX-501 and Rimiducid will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I have a blood cancer that may require a stem cell transplant.

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I am able to live my life with some degree of normalcy.

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My donor is at least a half match for me based on specific genetic markers.

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I am between 18 and 65 years old.

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Your bone marrow, heart, liver, kidneys, and lungs must be working well according to specific measurements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

BPX-501 Safety

GvHD

Rimiducid Activity

+2 more

Secondary outcome measures

Response Rate

Translational

Trial Design

1Treatment groups

Experimental Treatment

Group I: BPX-501 and RimiducidExperimental Treatment2 Interventions

All subjects will receive 3 cycles of BPX-501 T cell infusions at escalating dose levels (DL). DL1 on Day 0, DL2 on Days 30 and 60. The first dose of BPX-501 T cells will occur ≥30 days after hematopoietic stem cell transplant (HSCT). Two doses of Rimiducid ( 0.1 mg/kg and 0.4 mg/kg) will be investigated for the treatment of aGvHD after BPX-501 T cell infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

2019

Completed Phase 1

~20

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bellicum PharmaceuticalsLead Sponsor

27 Previous Clinical Trials

1,342 Total Patients Enrolled

2 Trials studying Lymphoma

66 Patients Enrolled for Lymphoma

Media Library

BPX-501 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02477878 — Phase 1

Lymphoma Research Study Groups: BPX-501 and Rimiducid

Lymphoma Clinical Trial 2023: BPX-501 Highlights & Side Effects. Trial Name: NCT02477878 — Phase 1

BPX-501 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02477878 — 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 settings are currently offering this test?

"At this time, 5 medical centres are recruiting study participants. These sites can be found in Westwood, Portland, Atlanta and two other cities. To make travel easier for those taking part in the trial, it's recommended to select a site close by."

Answered by AI

What potential hazards should people be aware of when using BPX-501?

"Due to the limited data on safety and efficacy, BPX-501 received a score of 1 for risk in this assessment."

Answered by AI

To what extent have other exploratory trials been conducted involving BPX-501?

"Currently, 16 clinical trials are ongoing for BPX-501 with none in their final phase. Most of these studies take place in Nashville, Tennessee although the research is being conducted at 94 separate sites."

Answered by AI

How can I participate in this medical experiment?

"The ideal candidates for this trial are individuals with multiple myeloma who range in age from 18 to 65 years old. Furthermore, they must also qualify under the following criteria: other high-risk hematologic malignancies eligible for stem cell transplantation according to their medical centre's standard; life expectancy of at least 10 weeks; lymphomas and mismatched related HSCTs."

Answered by AI

Is enrollment open to individuals below the age of eighty-five for this research project?

"The terms of inclusion for this medical trial dictate that participants must be at least 18 and not exceed 65 years old."

Answered by AI

Are there any opportunities for individuals to enroll in the trial?

"This particular trial is not recruiting members at this time, as it was last updated on July 10th of 2022. However, for those who are still interested in participating in a clinical study related to multiple myeloma or BPX-501, there are presently 3801 and 16 trials respectively actively seeking participants."

Answered by AI

What is the magnitude of individuals participating in this medical trial?

"At this time, recruitment for the clinical trial has been suspended. The study was first posted on July 1st 2016 and most recently updated on July 10th 2022. If you are looking for alternatives, there are currently 3801 trials search of patients with multiple myeloma and 16 studies actively recruiting participants for BPX-501."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant

2016. "Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02477878.

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