Not Yet RecruitingEarly Phase 1

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

18 participantsStarted 2026-05-09

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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)
. Creatinine ≤ 2 × ULN;
. Left ventricular ejection fraction (LVEF) ≥ 50%;
. Oxygen saturation \> 90%;
. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 month after treatment

Dose-limiting toxicities (DLTs)

Timeframe: 1 month after treatment

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

Timeframe: 1 month after treatment

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

Timeframe: 1 years after treatment

Trial details

NCT IDNCT07586709

SponsorLiping Dou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-31

Contact for this trial

Yu ZHAO

13601051848 zhaoyu301@126.com

View on ClinicalTrials.gov More Plasma Cell Neoplasms trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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)
. Creatinine ≤ 2 × ULN;
. Left ventricular ejection fraction (LVEF) ≥ 50%;
. Oxygen saturation \> 90%;
. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.

What they're measuring

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

Timeframe: 1 month after treatment

Dose-limiting toxicities (DLTs)

Timeframe: 1 month after treatment

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

Timeframe: 1 month after treatment

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

Timeframe: 1 years after treatment