Universal CAR-T Cells Targeting Multiple Myeloma

NCT06006741 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-23003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.

Conditions

Multiple Myeloma in Remission

Keywords

Universal CART; multiple myelomachimeric antigen BCMA CD38 CD56 CD138 CD19

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with treatment related adverse effect

  percentage of participants with treatment-related adverse events, as assessed by physical examination, vital signs, standard clinical lab tests.

  6 months

Secondary Outcomes (2)

• Anti-tumor activity of the universal 4SCAR-T cells after infusion

  3 months

• Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM

  1 year

Study Arms (1)

Universal CART cells to treat MM

EXPERIMENTAL

Biological: MM-specific universal CAR T cells

Interventions

MM-specific universal CAR T cells BIOLOGICAL

Infusion of MM-specific universal CAR T cells

Universal CART 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:

• Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).
• Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.
• High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.
• Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
• Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
• Residual disease after primary therapy and not eligible for ASCT
• Expected survival \> 12 weeks• Creatinine \< 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal
• Bilirubin \< 2.0 mg/dl
• Any relapse after prior SCT is eligible regardless of other prior therapy
• Adequate venous access for apheresis, and no other contraindications for leukapheresis
• Voluntary informed consent is signed

You may not qualify if:

• Pregnant or lactating women
• Uncontrolled active infection
• Active hepatitis B or hepatitis C infection
• Previous related CAR-T cell therapy
• Any uncontrolled active medical disorder that would preclude participation
• HIV infection

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-0755-8672 5195; c@szgimi.org

Ying Deng

CONTACT

86-0755-8672 5195; ying.deng@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: August 8, 2023
• First Posted: August 23, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)