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NCT03288493 · REGISTRY CONDITION SEARCH

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2024-03-28

Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1: Assess the Safety of P-BCMA-101

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outcome · POSTED

Phase 1: Maximum Tolerated Dose of P-BCMA-101

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outcome · POSTED

Phase 2: Assess the Safety of P-BCMA-101

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outcome · POSTED

Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)

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outcome · POSTED

Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)

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outcome · NOT POSTED

Phase 1:Assess the Safety of P-BCMA-101

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outcome · NOT POSTED

Phase 1:Assess the Feasibility P-BCMA-101

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outcome · NOT POSTED

Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)

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outcome · NOT POSTED

Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)

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outcome · NOT POSTED

Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)

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outcome · NOT POSTED

Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)

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outcome · NOT POSTED

Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)

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outcome · NOT POSTED

Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies

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outcome · NOT POSTED

Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)

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outcome · NOT POSTED

Phase 2: Evaluate Efficacy Endpoints (IL-6)

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outcome · NOT POSTED

Phase 2: Evaluate Efficacy Endpoints (C)

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outcome · NOT POSTED

Phase 2: Evaluate Efficacy Endpoints (R)

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outcome · NOT POSTED

Phase 2: Evaluate Efficacy Endpoints (OS)

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outcome · NOT POSTED

Phase 2: Evaluate Efficacy Endpoints (PFS)

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outcome · NOT POSTED

Phase 2: Evaluate Efficacy Endpoints (TTR)

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outcome · NOT POSTED

Phase 2: Evaluate Efficacy Endpoints (MRD)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Males or females, ≥18 years of age * Must have a confirmed diagnosis of active MM * Must have measurable MM * Must have relapsed / refractory MM, having received treatment with proteasome inhibitor and IMiD \[Phase 2: Must have relapsed / refractory MM, and refractory to last line of therapy, having received treatment with proteasome inhibitor, an IMiD, CD38 targeted therapy and undergone autologous stem cell transplant (ASCT) or not a candidate for ASCT.\] * Must have adequate hepatic, renal, cardiac and hematopoietic function Exclusion Criteria: * Is pregnant or lactating * Has inadequate venous access and/or contraindications to leukapheresis * Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, amyloidosis, significant autoimmune, CNS or other malignant disease * Has an active second malignancy (not disease-free for at least 5 years) in addition to MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma. * Has active autoimmune disease * Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc. * Has an active systemic infection * Has hepatitis B or C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. * Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol * Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry * Has CNS metastases or symptomatic CNS involvement * Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days. * Unable to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. (Cohorts R and RP only). * History of thromboembolic disease within the past 6 months, regardless of anticoagulation (Cohorts R and RP only).
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 1: P-BCMA-101 CAR-T cells
    type
    EXPERIMENTAL
  2. description
    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
    type
    EXPERIMENTAL
  3. description
    Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 1 P-BCMA-101 CAR-T cells (Cohort B)
    type
    EXPERIMENTAL
  4. description
    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 1 P-BCMA-101 CAR-T cells (Cohort C)
    type
    EXPERIMENTAL
  5. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)
    type
    EXPERIMENTAL
  6. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)
    type
    EXPERIMENTAL
  7. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)
    type
    EXPERIMENTAL
  8. description
    CAR-T cells administered via intravenous infusion as a total dose
    intervention Names
    1. Biological: P-BCMA-101 CAR-T cells
    2. Drug: Rimiducid
    label
    Phase 2: P-BCMA-101 CAR-T Cells
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
    2. Phase 1 P-BCMA-101 CAR-T cells (Cohort B)
    3. Phase 1 P-BCMA-101 CAR-T cells (Cohort C)
    4. Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)
    5. Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)
    6. Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)
    7. Phase 1: P-BCMA-101 CAR-T cells
    8. Phase 2: P-BCMA-101 CAR-T Cells
    description
    P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a "safety switch" gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.
    name
    P-BCMA-101 CAR-T cells
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
    2. Phase 1 P-BCMA-101 CAR-T cells (Cohort B)
    3. Phase 1 P-BCMA-101 CAR-T cells (Cohort C)
    4. Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)
    5. Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)
    6. Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)
    7. Phase 1: P-BCMA-101 CAR-T cells
    8. Phase 2: P-BCMA-101 CAR-T Cells
    description
    Rimiducid (safety switch activator) may be administered as indicated.
    name
    Rimiducid
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
intervention Model Description
Phase 1: open label, 3 + 3 design of dose-escalating cohorts Phase 2: open label, administered as a total dose
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
105
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Incidence and severity of treatment-emergent adverse events
    measure
    Phase 1: Assess the Safety of P-BCMA-101
    time Frame
    Baseline through Day 28
  2. description
    Rate of dose limiting toxicities (DLT)
    measure
    Phase 1: Maximum Tolerated Dose of P-BCMA-101
    time Frame
    Baseline through Day 28
  3. description
    Incidence and severity of treatment-emergent adverse events
    measure
    Phase 2: Assess the Safety of P-BCMA-101
    time Frame
    Baseline through 24 months
  4. description
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
    measure
    Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)
    time Frame
    Baseline through 24 months
  5. description
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
    measure
    Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)
    time Frame
    Baseline through 24 months
secondary Outcomes
  1. description
    Incidence and severity of treatment-emergent adverse events
    measure
    Phase 1:Assess the Safety of P-BCMA-101
    time Frame
    Baseline through Month 24
  2. description
    Ability to generate protocol-prescribed doses of P-BCMA-101.
    measure
    Phase 1:Assess the Feasibility P-BCMA-101
    time Frame
    Baseline through Month 24
  3. description
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
    measure
    Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)
    time Frame
    Baseline through Month 24
  4. description
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
    measure
    Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)
    time Frame
    Baseline through Month 24
  5. description
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
    measure
    Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)
    time Frame
    Baseline through Month 24
  6. description
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.
    measure
    Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)
    time Frame
    Baseline through Month 24
  7. description
    According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.
    measure
    Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)
    time Frame
    Baseline through Month 24
  8. description
    Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
    measure
    Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies
    time Frame
    Baseline through Month 24
  9. description
    Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
    measure
    Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)
    time Frame
    Baseline through Month 24
  10. description
    Rate of IL-6 antagonist
    measure
    Phase 2: Evaluate Efficacy Endpoints (IL-6)
    time Frame
    Baseline through Month 24
  11. description
    Corticosteroid Use
    measure
    Phase 2: Evaluate Efficacy Endpoints (C)
    time Frame
    Baseline through Month 24
  12. description
    Rimiducid Use
    measure
    Phase 2: Evaluate Efficacy Endpoints (R)
    time Frame
    Baseline through Month 24
Full study description
brief Summary
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.
detailed Description
Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient across 1-3 infusions, with or without combination therapy. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.
Source references
references
  1. citation
    Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27.
    pmid
    31215818
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    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice