BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT

NCT05846737 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IIT2023012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

  The incidence of treatment-emergent adverse events (TEAEs)

  Up to 2 year

• MRD-negativity rate

  Achieving undetectable MRD, as determined by NGF/NGS 3 months after CAR-T cell infusion

  3 months after CAR-T cell infusion

Secondary Outcomes (3)

• Complete response rate (CRR)

  1 month after the CAR-T cell transfusion, after consolidation therapy

• Progression free survival (PFS)

  Up to 2 year

• Overall Survival (OS)

  Up to 5 year

Other Outcomes (1)

• The CART cell duration in vivo

  Up to 1 year

Study Arms (1)

BCMA CAR-T in high-risk MM with detectable MRD after first-line ASCT

EXPERIMENTAL

Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA CAR+T cells/kg.

Biological: anti-BCMA CAR-T

Interventions

anti-BCMA CAR-T BIOLOGICAL

Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA CAR+T cells/kg.

BCMA CAR-T in high-risk MM with detectable MRD after first-line ASCT

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Participants with documented NDMM according to IMWG diagnostic criteria.
• High-risk MM, as determined by R2-ISS（J Clin Oncol, 2022,40(29):3406-3418.）, Stage III or Stage IV.
• Has received 3 to 6 cycles of induction therapy, followed by conditioning regimen and ASCT.
• Screening must be completed within 100 days of ASCT.
• For subjects receiving consolidation therapy after ASCT, screening must be completed within 60 days after consolidation therapy, and within 6 months after ASCT.
• Detectable MRD using EuroFlow or NGS, at 100 days after ASCT (minimum sensitivity of 10-5).
• All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: a.TBIL\<1.5 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT \<3 x ULN.; c. Creatinine clearance \> 60mL/min (calculated using the Cockroft-Gault formula).
• Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 85 g/L PLT ≥ 75 x 109/L (if BMPC \< 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%).
• Patients must be able to take prophylactic anticoagulant therapy as recommended by the study.
• The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter.

You may not qualify if:

• Primary plasma cell leukemia.
• Documented active amyloidosis.
• Multiple myeloma with central nervous system (CNS) invasion.
• Has received maintenance therapy.
• Prior exposure to any BCMA-targeted therapy or CAR-T therapy.
• Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy.
• Known intolerance, hypersensitivity, or contraindication to BCMA-CART cellular products.
• Seropositive for human immunodeficiency virus (HIV).
• Hepatitis B infection.
• Hepatitis C infection.
• Life expectancy of \<3 months.
• Women who are pregnant or breastfeeding.
• Subjects had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period.
• Received live attenuated vaccine within 4 weeks prior to study treatment.
• According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: May 29, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)