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New treatment option for Multiple Myeloma
Official title CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07249073
What this study is testing
What is CAR19-BCMA dual-target CAR-T?
CAR19-BCMA dual-target CAR-T is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- people must satisfy all the following criteria to be enrolled in the study: 1\. With people' consent and signed informed consent, people are willing...
- The expression of BCMA and / or CD19 in myeloma cells was positive confimed by flow cytometry or immunohistochemistry;
- Patients with relapsed / refractory multiple myeloma who have received at least 1 line treatment (including proteasome inhibitors (PI)...
- Creatinine ≤ 2 × ULN;
- Left ventricular ejection fraction ≥ 50%;
You likely can't join if
- If any of the following criteria is met, you cannot be enrolled:
- 1\. There were severe cardiac insufficiency and left ventricular ejection fraction \<50%; 2. Have a history of severe lung function impairment...
See the full eligibility criteria
- people must satisfy all the following criteria to be enrolled in the study: 1\. With people' consent and signed informed consent, people are willing and able to follow the planned visit, study treatment, laboratory...
- The expression of BCMA and / or CD19 in myeloma cells was positive confimed by flow cytometry or immunohistochemistry;
- Patients with relapsed / refractory multiple myeloma who have received at least 1 line treatment (including proteasome inhibitors (PI), immunomodulatory drugs (IMID), CD38 mAb) or are resistant to proteasome inhibitors...
- Creatinine ≤ 2 × ULN;
- Left ventricular ejection fraction ≥ 50%;
- Blood oxygen saturation \>90%;
- Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. people with pregnancy plans must agree to take contraception before enrollment in the study and after six months of study duration; The investigator should be...
- If any of the following criteria is met, you cannot be enrolled:
- 1\. There were severe cardiac insufficiency and left ventricular ejection fraction \<50%; 2. Have a history of severe lung function impairment disease; 3. Combined with other advanced malignant tumors; 4. It was...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.