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

NCT02477878 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: BP-008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of increasing doses of BPX-501 T cell infusions to achieve a clinical response. Rimiducid will be investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose that can mitigate GvHD and preserve the graft versus leukemia effect.

Conditions

Leukemia; Myelodysplastic Syndromes; Lymphoma; Multiple Myeloma; Hematologic Neoplasms

Keywords

Adult leukemias and myelodysplasia; Adult lymphomas; Adult multiple myeloma; allogeneic stem cell transplant; donor lymphocyte infusion

Outcome Measures

Primary Outcomes (5)

• BPX-501 Safety

  To evaluate the safety of 2 stratified dose levels of BPX-501 T cell infusions based on patient-donor match in adult subjects with hematological malignancies

  Month 24

• Rimiducid Safety

  evaluate the safety of the infusion of escalating doses of dimerizer drug rimiducid (AP1903) in subjects who develop acute GvHD after BPX-501 infusion

  Month 24

• GvHD

  Assess incidence and severity of acute and chronic GvHD

  Month 24

• Rimiducid Activity

  Determine the effect of Rimiducid on mitigating GvHD

  Month 24

• Rimiducid Efficacy

  Assess time to resolution of GvHD after administration of Rimiducid

  Month 24

Secondary Outcomes (2)

• Response Rate

  Month 24

• Translational

  Month 24

Study Arms (1)

BPX-501 and Rimiducid

EXPERIMENTAL

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.

Biological: BPX-501; Drug: Rimiducid

Interventions

BPX-501 BIOLOGICAL

Biological: T cells transduced with CaspaCIDe suicide gene

BPX-501 and Rimiducid

Rimiducid DRUG

Rimiducid administered to treat GVHD

Also known as: AP1903

BPX-501 and Rimiducid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged \>18yrs and \< 65yrs
• 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 Life expectancy \>10 weeks
• Evidence of recurrent disease that presents \> 100 days or minimal residual disease (MRD) that presents \> 30 days after one of the following:
• Matched related HSCT
• Mismatched related HSCT
• Signed patient informed consent;
• A minimum genotypic identical match of 4/8 is required, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1
• Performance status: Karnofsky score \> 50%
• Subjects with adequate organ function as measured by:
• Bone marrow:

You may not qualify if:

• ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening;
• Active CNS involvement by malignant cells;
• Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings). The principal investigator is the final arbiter of this criterion;
• Positive HIV serology or viral RNA
• Pregnancy (positive serum βHCG test) or breast-feeding;
• Subjects of reproductive potential unwilling to use effective forms of birth control or abstinence for a year after transplantation;
• Bovine product allergy

Sponsors & Collaborators

• Bellicum Pharmaceuticals: lead

Study Sites (5)

BMT Program at Northside Hospital

Atlanta, Georgia, 30342, United States

Location

University of Kansas

Westwood, Kansas, 66205, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Lymphoma; Multiple Myeloma; Hematologic Neoplasms; Anemia, Refractory, with Excess of Blasts

Interventions

AP 1903 reagent

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Neoplasms by Site; Anemia, Refractory; Anemia

Study Officials

• Bellicum Pharmaceuticals

  Bellicum Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: June 23, 2015
• Study Start: July 1, 2016
• Primary Completion: January 14, 2020
• Study Completion (Estimated): January 1, 2033
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)