Clinical trial · Interventional
Safety and Efficiency Study of BCMA-PD1-CART Cells in Relapsed/Refractory Multiple Myeloma
NCT04162119CI-TRIAL-00041689unknownPhase 2ClinicalTrials.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 is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with relapsed/refractory Multiple Myeloma.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA-PD1-CART Cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- multiple myeloma
- description
- This study is to evaluate the efficacy and safety of BCMA-PD1-CART cells therapy for patients with Relapsed/Refractory Multiple Myeloma.
- interventionNames
- Biological: BCMA-PD1-CART Cell
Primary outcomes (1)
- measure
- Incidence of Treatment-related Adverse Events
- timeFrame
- 3 years
- description
- Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
Secondary outcomes (5)
- measure
- Overall Remission Rate(ORR) of BCMA-PD1-CART cells in Lymphoma
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, aged 14 to 80 years (including 14 and 80 years old). 2. The diagnosis was Refractory/relapsed multiple myeloma.(Meeting 1 of the follow 3 items) A.Primary treatment patients with no effect after first and second line treatment. B.Patients who relapsed after complete remission and failed to respond to two kind of therapy. C.the predicted survival is more than three months. 3. Flow cytometry or immunohistochemistry showed BCMA positive in tumor cells. 4. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form. 5. No serious concomitant disease and major organ function is not serious abnormal. 6. No serious concomitant disease and major organ function is not serious abnormal. 7. the test meets the following indicators: A.ALT/AST \< 2.5 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L. B.WBC≥2.5×109/L. C.PT/INR \< 1.7 or PT was extended by less than 4 seconds. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Transduced positive T lymphocytes \< 5% or amplified against CD3/CD28 stimulation \< 5 times. 3. Active hepatitis B or hepatitis C, HIV/AIDS infection, any uncontrolled active infection. 4. Patients who are using steroid drugs throughout the body currently. 5. Patients who have received any gene therapy in the past. 6. Patients who are allergy to immunotherapy and related drugs. 7. Patients with heavy heart disease or poorly controlled high blood pressure. 8. Patients who received chemotherapy or radiation 4 weeks before the study began. 9. Patients who are participating in other clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.