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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

Must not have

Autologous hematopoietic stem cell transplant < 3 months prior to enrollment

Evidence of HIV infection or known HIV positive serology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I had a stem cell transplant using my own cells less than 3 months ago.

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I am HIV positive.

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I do not have any ongoing serious infections.

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I have had a stem cell transplant from a donor.

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I have been diagnosed with primary idiopathic myelofibrosis.

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I have a donor who is a perfect match for my transplant.

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I haven't had cancer other than skin cancer in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

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

Primary study objectives

BPX-501 Safety

Immune Reconstitution

MTD

+1 more

Secondary study objectives

BPX-501 Safety Profile

Efficacy- DFS

Efficacy- NRM

+6 more

Awards & Highlights

No Placebo-Only Group

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

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

0 / 15Eligibility criteria met