Universal CAR-T Cells Targeting Multiple Myeloma

Universal CAR-T Cells for the Treatment of Multiple Myeloma

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma in Remission
• Intervention / Treatment: Biological: MM-specific universal CAR T cells

Detailed Description

Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT).

CAR-T therapy has proven to be a revolutionary treatment for hematological malignancies, but its manufacture is still limited by the high cost, and a long preparation time that is not conducive to timely treatment of patients. In addition, many MM patients suffer from long-term bone marrow suppression caused by tumor growth or prolonged and intense chemotherapies, resulting in exhaustion, aging and functional defects of autologous T cells, which substantially affect the quality of CAR-T cells and the clinical efficacy. The universal CAR-T cells could overcome many of the above problems.

By using universal type of CAR-T cells, the product can be supplied off-the-shelf without being customized from individual patients. In addition, the immediate availability means that patients under severe bone marrow suppression may get a chance to be treated with CAR-T cells to achieve disease remission. In addition, those patients who suffer from long-term immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have the option of treatment with the universal CAR-T cells.

The purpose of this study is to assess the feasibility, safety and efficacy of several 4SCAR designs including BCMA, CD138, CD38 and CD19-specific universal CAR-T products targeting MM. Another goal is to learn more about the function of these universal CAR T cells and their persistency in the patients.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Deng; Phone Number: 86-0755-8672 5195; Email: ying.deng@szgimi.org
• Study Contact Backup: Name: Lung-Ji Chang, PhD; Phone Number: 86-0755-8672 5195; Email: c@szgimi.org

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • Shenzhen Geno-immune Medical Institute
      • Contact: Lung-Ji Chang, PhD; Phone Number: 86-0755-86725195; Email: c@szgimi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant or lactating women
2. Uncontrolled active infection
3. Active hepatitis B or hepatitis C infection
4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
5. Previous related CAR-T cell therapy
6. Any uncontrolled active medical disorder that would preclude participation
7. HIV infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Universal CART cells to treat MM	Biological: MM-specific universal CAR T cells; Infusion of MM-specific universal CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-tumor activity of the universal 4SCAR-T cells after infusion	CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.	3 months
Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM	Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.	1 year

Collaborators and Investigators

• Sponsor: Shenzhen Geno-Immune Medical Institute
• Collaborators: The Second Affiliated Hospital of Hainan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Universal CART; multiple myelomachimeric antigen BCMA CD38 CD56 CD138 CD19
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: GIMI-IRB-23003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No