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New treatment option for Relapsed or Refractory B-cell Lymphoma
Official title Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
ClinicalTrials.gov ID: NCT05806580
What this study is testing
What is Relma-cel?
Relma-cel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory b-cell lymphoma.
Also referred to as JWCAR029.
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
- To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients have signed an Informed Consent Form (ICF).
- Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel.
- Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second...
- Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\^6 CAR-T cells), with specific dosage...
- Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.
You likely can't join if
- Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infections
See the full eligibility criteria
- Patients have signed an Informed Consent Form (ICF).
- Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel.
- Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second treatment (including PR/PD/SD) based on clinical practice.
- Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\^6 CAR-T cells), with specific dosage determined by the investigator based on patient condition and dose...
- Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.
- Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the second treatment.
- Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels before retreatment.
- Patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment.
- Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infections
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai 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.