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TerminatedNCT03288493Updated Mar 28, 2024Results posted

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

A Phase 1/2 interventional study of P-BCMA-101 CAR-T cells and Rimiducid in Multiple Myeloma, sponsored by Poseida Therapeutics, Inc.. Terminated at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Poseida Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Phase I portion of the study was completed. The phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
Phase
Phase 1/2
Study type
Interventional
Enrollment
105
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • CAR-T cells
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Phase 1: P-BCMA-101 CAR-T cells

    Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

  • Experimental
    Phase 1 P-BCMA-101 CAR-T cells (Cohort A)

    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

  • Experimental
    Phase 1 P-BCMA-101 CAR-T cells (Cohort B)

    Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

  • Experimental
    Phase 1 P-BCMA-101 CAR-T cells (Cohort C)

    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

  • Experimental
    Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)

    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

  • Experimental
    Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)

    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

  • Experimental
    Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)

    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

  • Experimental
    Phase 2: P-BCMA-101 CAR-T Cells

    CAR-T cells administered via intravenous infusion as a total dose

    Biological: P-BCMA-101 CAR-T cells · Drug: Rimiducid

Interventions

  • BiologicalP-BCMA-101 CAR-T cells

    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.

  • DrugRimiducid

    Rimiducid (safety switch activator) may be administered as indicated.

05

What researchers measure

Primary outcomes

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

    Incidence and severity of treatment-emergent adverse events

    Time frame: Baseline through Day 28

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

    Rate of dose limiting toxicities (DLT)

    Time frame: Baseline through Day 28

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

    Incidence and severity of treatment-emergent adverse events

    Time frame: Baseline through 24 months

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

    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).

    Time frame: Baseline through 24 months

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

    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.

    Time frame: Baseline through 24 months

Secondary outcomes

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

    Incidence and severity of treatment-emergent adverse events

    Time frame: Baseline through Month 24

  2. Phase 1:Assess the Feasibility P-BCMA-101

    Ability to generate protocol-prescribed doses of P-BCMA-101.

    Time frame: Baseline through Month 24

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

    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).

    Time frame: Baseline through Month 24

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

    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.

    Time frame: Baseline through Month 24

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

    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.

    Time frame: Baseline through Month 24

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

    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.

    Time frame: Baseline through Month 24

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

    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.

    Time frame: Baseline through Month 24

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

    Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)

    Time frame: Baseline through Month 24

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

    Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)

    Time frame: Baseline through Month 24

  10. Phase 2: Evaluate Efficacy Endpoints (IL-6)

    Rate of IL-6 antagonist

    Time frame: Baseline through Month 24

  11. Phase 2: Evaluate Efficacy Endpoints (C)

    Corticosteroid Use

    Time frame: Baseline through Month 24

  12. Phase 2: Evaluate Efficacy Endpoints (R)

    Rimiducid Use

    Time frame: Baseline through Month 24

  13. Phase 2: Evaluate Efficacy Endpoints (OS)

    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.

    Time frame: Baseline through Month 24

  14. Phase 2: Evaluate Efficacy Endpoints (PFS)

    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.

    Time frame: Baseline through Month 24

  15. Phase 2: Evaluate Efficacy Endpoints (TTR)

    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.

    Time frame: Baseline through Month 24

  16. Phase 2: Evaluate Efficacy Endpoints (MRD)

    Minimum residual disease negative rate

    Time frame: Baseline through Month 24

06

Results

Posted Jun 22, 2023

Participant flow

Participant flow — Overall Study
MilestonePhase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T Cells
Started693185163
Completed3000000
Not completed663185163
Withdrew: Withdrawal by subject4000020
Withdrew: Significant progression of malignancy requiring alternative, medical, radiation or surgical interven523165103
Withdrew: Termination of the study by the pi, the sponsor, the study funder, the irb/iec or the fda6002040
Withdrew: Death2000000
Withdrew: Other reason not listed above2000000

Outcome measures

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

Incidence and severity of treatment-emergent adverse events

Time frame:
Baseline through Day 28
Reported as:
Count of participants · Participants
Phase 1: Assess the Safety of P-BCMA-101
ParticipantsPhase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
TEAE Related to P-BCMA-10156307213
TEAE Not Related to P-BCMA-1011101133
PrimaryPhase 1: Maximum Tolerated Dose of P-BCMA-101

Rate of dose limiting toxicities (DLT)

Time frame:
Baseline through Day 28
Reported as:
Count of participants · Participants
Phase 1: Maximum Tolerated Dose of P-BCMA-101
ParticipantsPhase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T Cells
Phase 1: Maximum Tolerated Dose of P-BCMA-101000000NA
PrimaryPhase 2: Assess the Safety of P-BCMA-101

Incidence and severity of treatment-emergent adverse events

Time frame:
Baseline through 24 months
Reported as:
Count of participants · Participants
Phase 2: Assess the Safety of P-BCMA-101
ParticipantsPhase 2: P-BCMA-101 CAR-T Cells
TEAE Related to P-BCMA-1012
TEAE Not Related to P-BCMA-1011
PrimaryPhase 2: Assess the Efficacy of P-BCMA-101 (ORR)

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).

Time frame:
Baseline through 24 months

No measurements were reported for this outcome.

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

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.

Time frame:
Baseline through 24 months

No measurements were reported for this outcome.

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

Incidence and severity of treatment-emergent adverse events

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 1:Assess the Feasibility P-BCMA-101

Ability to generate protocol-prescribed doses of P-BCMA-101.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

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

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).

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

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

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.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

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

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.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

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

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.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

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

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.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

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

Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

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

Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 2: Evaluate Efficacy Endpoints (IL-6)

Rate of IL-6 antagonist

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 2: Evaluate Efficacy Endpoints (C)

Corticosteroid Use

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 2: Evaluate Efficacy Endpoints (R)

Rimiducid Use

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 2: Evaluate Efficacy Endpoints (OS)

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.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 2: Evaluate Efficacy Endpoints (PFS)

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.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 2: Evaluate Efficacy Endpoints (TTR)

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.

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

SecondaryPhase 2: Evaluate Efficacy Endpoints (MRD)

Minimum residual disease negative rate

Time frame:
Baseline through Month 24

Results for this outcome have not been posted.

Adverse events

Collected over Baseline through Month 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1: P-BCMA-101 CAR-T Cells23/69 (33.3%)39/69 (56.5%)63/69 (91.3%)
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)0/3 (0%)1/3 (33.3%)3/3 (100%)
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)0/1 (0%)1/1 (100%)1/1 (100%)
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)3/8 (37.5%)7/8 (87.5%)7/8 (87.5%)
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)1/5 (20%)2/5 (40%)5/5 (100%)
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)0/16 (0%)6/16 (37.5%)16/16 (100%)
Phase 2: P-BCMA-101 CAR-T Cells1/3 (33.3%)2/3 (66.7%)3/3 (100%)
Retreatment2/5 (40%)2/5 (40%)4/5 (80%)
Most frequent serious events
Showing 10 of 57
Most frequent serious events
EventPhase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T CellsRetreatment
Febrile neutropeniaBlood and lymphatic system disorders16/691/31/12/80/51/160/31/5
Cytokine release syndromeImmune system disorders6/690/30/13/80/52/161/30/5
Progressive multifocal leukoencephalopathyInfections and infestations0/690/30/10/80/50/161/30/5
Urinary tract infectionInfections and infestations0/690/30/10/80/50/161/30/5
PneumoniaInfections and infestations6/690/30/11/80/51/160/31/5
PancytopeniaBlood and lymphatic system disorders0/690/30/10/81/50/160/30/5
Staphylococcal bacteraemiaInfections and infestations0/690/30/10/81/50/160/30/5
HypervolaemiaMetabolism and nutrition disorders0/690/30/10/80/50/160/31/5
ArthralgiaMusculoskeletal and connective tissue disorders0/690/30/10/80/50/160/31/5
Transfusion reactionInjury, poisoning and procedural complications0/690/30/10/80/50/160/31/5
Most frequent other events
Showing 10 of 38
Most frequent other events
EventPhase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T CellsRetreatment
NeutropeniaBlood and lymphatic system disorders48/693/30/13/85/513/162/33/5
ThrombocytopeniaBlood and lymphatic system disorders32/693/30/15/82/56/162/33/5
AnaemiaBlood and lymphatic system disorders33/691/31/12/83/55/162/32/5
LeukopeniaBlood and lymphatic system disorders20/693/31/13/81/56/162/33/5
Decreased appetiteMetabolism and nutrition disorders12/690/31/12/80/52/161/31/5
DiarrhoeaGastrointestinal disorders19/691/30/12/80/56/162/30/5
FatigueGeneral disorders22/692/30/15/81/55/161/31/5
Musculoskeletal painMusculoskeletal and connective tissue disorders5/692/30/11/80/51/160/30/5
HeadacheNervous system disorders13/692/30/10/81/52/160/30/5
PyrexiaGeneral disorders19/690/30/13/80/53/161/30/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T CellsTotal
<=18 years00000000
Between 18 and 65 years3921538260
>=65 years3010328145
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T CellsTotal
Female2301427239
Male4630439166
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T CellsTotal
Hispanic or Latino50001107
Not Hispanic or Latino60318314392
Unknown or Not Reported40001106
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T CellsTotal
American Indian or Alaska Native00000000
Asian11000103
Native Hawaiian or Other Pacific Islander00000000
Black or African American1310203120
White48116310271
More than one race00000000
Unknown or Not Reported700022011
Region of Enrollment
Region of Enrollment(participants)Phase 1: P-BCMA-101 CAR-T CellsPhase 1 P-BCMA-101 CAR-T Cells (Cohort A)Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)Phase 2: P-BCMA-101 CAR-T CellsTotal
United States693185163105
07

Study locations

16 sites
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • University of California Davis
    Davis, California 95618, United States
  • University of California San Diego
    San Diego, California 92093, United States
  • University of California San Francisco
    San Francisco, California 94143, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • University of Kansas Cancer Center
    Westwood, Kansas 66205, United States
  • University of Maryland Greenebaum Comprehensive Cancer Center
    Baltimore, Maryland 21201, United States
  • Johns Hopkins University
    Baltimore, Maryland 21231, United States
  • Wayne State - Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • John Theurer Cancer Center
    Hackensack, New Jersey 07601, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Sarah Cannon Research Institute at Tennessee Oncology
    Nashville, Tennessee 37203, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Swedish Cancer Institute
    Seattle, Washington 98104, United States
08

References and documents

Publications

  • 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. PubMed 31215818 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 20, 2019

Documents are hosted by the registry — open the source record to download them.

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Registry details

Key details

Study ID
NCT03288493
Lead sponsor
Poseida Therapeutics, Inc.
Collaborators
California Institute for Regenerative Medicine (CIRM)
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Sep 20, 2017
Primary completion
Apr 27, 2022
Completion
Apr 27, 2022
Results posted
Jun 22, 2023
Last update
Mar 28, 2024

Study contacts

Rajesh Belani, M.D.
study director · Sponsor Executive Medical Director

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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