Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

NCT06429150 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-24001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.

Conditions

Multiple Myeloma; Plasmacytoma

Keywords

multiple myeloma; chimeric antigen receptor; BCMA; GPRC5D

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with treatment related adverse effects

  The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0

  1 month

Secondary Outcomes (2)

• Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion

  1 year

• Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma

  1 year

Study Arms (1)

CAR-T cells to treat MM

EXPERIMENTAL

Biological: CAR-T cells

Interventions

CAR-T cells BIOLOGICAL

Infusion of multi-CAR-T cells

CAR-T cells to treat MM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects with multiple myeloma or plasmacytoma
• Strictly complete remission (sCR) is a treatment goal
• Expected survival \> 12 weeks
• After prior auto-SCT is eligible regardless of other prior therapies
• Adequate venous access for apheresis, and no other contraindications for leukapheresis
• Voluntary informed consent is given and commitment to continued follow-up

You may not qualify if:

• Pregnant or lactating women
• Uncontrolled active infection
• Active HIV, hepatitis B or hepatitis C infection
• Any medical conditions that may preclude participation

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead
• The No.2 Clinical Hospital of the Ministry of Health: collaborator

Study Sites (2)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Hematologist of the Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health

Vladivostok, 690105, Russia

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Plasmacytoma

Interventions

Immunotherapy, Adoptive

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Lung-Ji Chang, ph.D

CONTACT

86-0755 86725195; c@szgimi.org

Study Design

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

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 24, 2024
• Study Start: May 11, 2024
• Primary Completion (Estimated): July 11, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1); CN (1)