Active — Not RecruitingPhase 1

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

United States275 participantsStarted 2022-05-05

Plain-language summary

Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have signed written, informed consent.
✓. 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 a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
✓. Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-BCMA-ALLO1 administration.
✓. Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion therapy regimen (females of childbearing potential).
✓. Must be at least 90 days since autologous stem cell transplant, if performed.

Exclusion criteria

✕. Is pregnant or lactating.
✕. Has inadequate venous access.
✕. Has active hemolytic anemia, plasma cell leukemia, Waldenstrom\&#39;s macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, or amyloidosis.
✕. 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 a history of hepatitis B, hepatitis C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by Hepatitis C PCR on multiple occasions.

What they're measuring

Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)

Timeframe: Baseline through Day 28

Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells.

Timeframe: Baseline through 36 months

Phase 1b: The effect of cell dose and study arm

Timeframe: Baseline through 36 months

Trial details

NCT IDNCT04960579

SponsorPoseida Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-03

View on ClinicalTrials.gov More Multiple Myeloma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have signed written, informed consent.
✓. 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 a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
✓. Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-BCMA-ALLO1 administration.
✓. Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion therapy regimen (females of childbearing potential).
✓. Must be at least 90 days since autologous stem cell transplant, if performed.

Exclusion criteria

✕. Is pregnant or lactating.
✕. Has inadequate venous access.
✕. Has active hemolytic anemia, plasma cell leukemia, Waldenstrom\&#39;s macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, or amyloidosis.
✕. 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 a history of hepatitis B, hepatitis C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by Hepatitis C PCR on multiple occasions.

What they're measuring

Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)

Timeframe: Baseline through Day 28

Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells.

Timeframe: Baseline through 36 months

Phase 1b: The effect of cell dose and study arm

Timeframe: Baseline through 36 months