Clinical trial · Interventional
In Vivo BCMA/GPRC5D Tandem Dual CAR-T Therapy for Relapsed/Refractory Plasma Cell Neoplasms
A Clinical Study on the Safety of in Vivo-CAR-T Cell Immunotherapy Targeting BCMA/GPRC5D for the Treatment of Relapsed/Refractory Plasma Cell Neoplasms
NCT07586709CI-TRIAL-00111500not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plasma Cell Neoplasms | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In vivo BCMA/GPRC5D Tandem Dual CAR-T cell | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- In vivo BCMA/GPRC5D Tandem Dual CAR-T
- description
- Participants receive treatment of In vivo BCMA/GPRC5D Tandem Dual CAR-T cell following a 3+3 dose-escalation design.
- interventionNames
- Drug: In vivo BCMA/GPRC5D Tandem Dual CAR-T cell
Primary outcomes (4)
- measure
- Number and incidence rate with Each Grade of Cytokine Release Syndrome (CRS)
- timeFrame
- 1 month after treatment
- description
- 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.
- measure
- Dose-limiting toxicities (DLTs)
- timeFrame
- 1 month after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry; 2. 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): 1. Creatinine ≤ 2 × ULN; 2. Left ventricular ejection fraction (LVEF) ≥ 50%; 3. Oxygen saturation \> 90%; 4. 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. Exclusion Criteria: * 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).
References
Publications (0)
Data not yet available
No reference posted for this study.