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CAR T-cell Therapy

Gene Modified T-cells + Stem Cell Transplant for Leukemia

Phase 1 & 2
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
Deemed eligible for allogeneic stem cell transplantation
Lack of suitable conventional donor or presence of rapidly progressive disease not permitting time to identify an unrelated donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will evaluate whether adding T cells back to stem cells from a partially matched relative can help the immune system recover post-transplant.

Who is the study for?
Adults aged 18-65 with certain blood cancers like leukemia or lymphoma, who lack a fully matched stem cell donor and are eligible for a transplant. Participants must have at least a half-matched (4/8) donor available, good organ function, and specific types of cancer in remission or high-risk states.Check my eligibility
What is being tested?
The trial is testing genetically modified T-cells from partially matched donors after stem cell transplants to see if they can help the immune system recover faster. These T-cells have a 'self-destruct switch' to prevent them from attacking the patient's body.See study design
What are the potential side effects?
Potential side effects may include reactions related to graft versus host disease (GVHD), where the new cells attack the patient’s tissues. The self-destruct switch aims to reduce this risk by destroying problematic T-cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a stem cell transplant from a donor.
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I don't have a matching donor or my disease is worsening too quickly.
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My donor and I share at least one genetic match in specific areas.
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I have been diagnosed with a specific blood cancer.
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I am able to care for myself but may not be able to do active work.
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My blood cancer hasn't responded to standard treatments, and the trial sponsor has approved my participation.
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I am between 18 and 65 years old.
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My HLA typing matches at least half of the required markers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months 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
Immune Reconstitution
MTD
+1 more
Secondary outcome measures
BPX-501 Safety Profile
Efficacy- DFS
Efficacy- NRM
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: SCT, BPX-501 dose 4, Rimiducid if neededExperimental Treatment3 Interventions
3x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant . Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.
Group II: SCT, BPX-501 dose 3, Rimiducid if neededExperimental Treatment3 Interventions
1x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant. Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.
Group III: SCT, BPX-501 dose 2, Rimiducid if neededExperimental Treatment3 Interventions
5x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant. Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.
Group IV: SCT, BPX-501 dose 1, Rimiducid if neededExperimental Treatment3 Interventions
2x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant. Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimiducid
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Bellicum PharmaceuticalsLead Sponsor
26 Previous Clinical Trials
1,274 Total Patients Enrolled
2 Trials studying Lymphoma
40 Patients Enrolled for Lymphoma

Media Library

BPX-501 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01744223 — Phase 1 & 2
Lymphoma Research Study Groups: SCT, BPX-501 dose 4, Rimiducid if needed, SCT, BPX-501 dose 1, Rimiducid if needed, SCT, BPX-501 dose 2, Rimiducid if needed, SCT, BPX-501 dose 3, Rimiducid if needed
Lymphoma Clinical Trial 2023: BPX-501 Highlights & Side Effects. Trial Name: NCT01744223 — Phase 1 & 2
BPX-501 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01744223 — Phase 1 & 2

Frequently Asked Questions

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

Is enrollment for this trial still open?

"At present, this trial is not enrolling new participants. It was posted on the 1st of March 2013 and revised for the last time on July 10th 2022. If you are seeking out other studies to join, there are 3086 clinical trials available that accept patients with myelodysplastic syndromes while 16 trials actively admit those treated with Rimiducid."

Answered by AI

Who qualifies as a suitable participant for this clinical research?

"This trial is currently enrolling 36 people aged between 18 and 65 who exhibit myelodysplastic syndromes. Furthermore, patients must satisfy other important criteria such as providing informed consent for the procedure, being eligible for allogeneic stem cell transplantation, lacking a suitable donor or showing signs of rapidly progressing disease that cannot be addressed by an unrelated donor, having HLA-A to DRB1 alleles at least 4/8 identical with those of the recipient's genotype through high resolution typing, exhibiting left ventricular ejection fraction rest higher than 45%, presenting bilirubin levels below 2.5 mg/dL"

Answered by AI

What is the ambition behind this clinical exploration?

"This 24-month clinical trial will measure the safety of BPX-501. Additionally, researchers will assess efficacy and relapse rate, time for resolution of acute GvHD post Rimiducid administration, as well as incidence and severity of both acute and chronic GvHD."

Answered by AI

Is the participation of individuals aged 40 and above being solicited for this research endeavor?

"This trial is accepting patients ages 18 to 65 only. For those that are younger or older, 679 and 2681 research studies offer alternative options respectively."

Answered by AI

Have any other investigations been done on Rimiducid's efficacy?

"Currently, 16 Rimiducid trials are active with none in the third phase. San Diego is a hub for these types of studies, but there are 94 other sites worldwide facilitating clinical research related to this drug."

Answered by AI

In which geographic locations is this research project active?

"This trial is being conducted across 8 different centres, located in cities such as Buffalo, Cleveland and Portland. Participants are encouraged to select the site closest to them for convenience's sake."

Answered by AI

How many participants is this inquiry seeking to include?

"Unfortunately, the recruitment process for this trial has currently stalled. It was first listed on March 1st 2013 and last modified on July 10th 2022. On the other hand, there are 3086 studies actively enrolling patients with myelodysplastic syndromes and 16 clinical trials utilizing Rimiducid that have open spots available."

Answered by AI
~3 spots leftby Mar 2025