In Vivo BCMA/GPRC5D Tandem Dual CAR-T Therapy for Relapsed/Refractory Plasma Cell Neoplasms

NCT07586709 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2026-172-02
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the safety profile of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.

Conditions

Plasma Cell Neoplasms

Keywords

in vivo CAR-T Cell Therapy; BCMA; GPRC5D; plasma cell neoplasms

Outcome Measures

Primary Outcomes (4)

• Number and incidence rate with Each Grade of Cytokine Release Syndrome (CRS)

  CRS severity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading. The grade ranges from 1 to 4, where a higher grade indicates a worse outcome.

  1 month after treatment

• Dose-limiting toxicities (DLTs)

  Dose limiting toxicity will be assessed after injection

  1 month after treatment

• Number and incidence rate of Each Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

  ICANS severity is graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading, which incorporates the Immune Effector Cell-Associated Encephalopathy (ICE) assessment. The ICE score ranges from 0 to 10, with higher scores indicating better cognitive function. ICANS grade ranges from 1 to 4, where a higher grade indicates a worse outcome.

  1 month after treatment

• Number and incidence rate of Treatment-Associated Adverse Events (AEs)

  All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

  1 years after treatment

Secondary Outcomes (9)

• Overall Objective Response Rate (ORR)

  Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment

• overall survival (OS)

  2 years after treatment

• progression free survival (PFS)

  2 years after treatment

• duration of response (DOR)

  2 years after treatment

• time to progression (TTP)

  2 years after treatment

Study Arms (1)

In vivo BCMA/GPRC5D Tandem Dual CAR-T

EXPERIMENTAL

Participants receive treatment of In vivo BCMA/GPRC5D Tandem Dual CAR-T cell following a 3+3 dose-escalation design.

Drug: In vivo BCMA/GPRC5D Tandem Dual CAR-T cell

Interventions

In vivo BCMA/GPRC5D Tandem Dual CAR-T cell DRUG

Administration of in vivo BCMA/GPRC5D tandem dual CAR-T cells. Three dose levels (dose A, dose B, dose C) will be evaluated using a standard 3+3 dose-escalation design.

Also known as: SL4903

In vivo BCMA/GPRC5D Tandem Dual CAR-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
• Diagnosis of relapsed or refractory plasma cell neoplasms meeting the following criteria:
• Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry;
• Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria)
• Age 18 to 75 years (inclusive), male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Life expectancy \> 3 months from the date of informed consent.
• Hemoglobin (HGB) ≥ 60 g/L (transfusion allowed).
• Adequate organ function (hepatic, renal, cardiac, and pulmonary):
• Creatinine ≤ 2 × ULN;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• Oxygen saturation \> 90%;
• Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.
• Willingness to use highly effective contraception from signing of informed consent until 1 year after SL4903 infusion.

You may not qualify if:

• Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \< 50%.
• History of severe pulmonary impairment.
• Concurrent diagnosis of another active malignancy.
• Uncontrolled active infection.
• History of severe autoimmune disease or primary immunodeficiency.
• Active hepatitis (defined as HBV DNA or HCV RNA above the lower limit of detection).
• Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or active syphilis.
• History of severe hypersensitivity to biological products (including antibiotics).
• Allogeneic hematopoietic stem cell transplant recipients with ongoing acute graft-versus-host disease (GVHD) despite discontinuation of immunosuppressive therapy for at least one month prior to screening.
• Any other severe comorbidities or laboratory abnormalities that, in the investigator's opinion, would increase the risk to the subject or interfere with study results, rendering the subject unsuitable for participation.
• Pregnant or breastfeeding women (including women of childbearing potential who are pregnant or lactating).

Sponsors & Collaborators

• Liping Dou: lead

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Liping DOU

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu ZHAO

CONTACT

13601051848; zhaoyu301@126.com

Study Design

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

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 14, 2026
• Study Start: May 9, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05