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New treatment option for Non Hodgkin Lymphoma
Official title PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
ClinicalTrials.gov ID: NCT06522932
What this study is testing
What is 64Cu-GRIP B?
64Cu-GRIP B is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non hodgkin lymphoma.
Also referred to as granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B.
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
- This is a phase I/Ib imaging study of granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64Cu-GRIP B) Positron Emission Tomography (PET) in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) receiving CD19-directed Chimeric antigen receptor T cells (CAR-T) therapy. The proposed study represents the first-ever lymphoma patient imaging studies with 64Cu-GRIP B PET.
- 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 and older. Healthy volunteers may be eligible.
You may be able to join if
- Disease characteristics, as defined by:
- Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) with at least one prior line of therapy.
- Planned treatment with a commercially available CD19 targeting CAR-T cell product.
- Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion.
- Age \>= 18 years.
You likely can't join if
- Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
- Pregnant participants are excluded from this study because the effects of 64Cu-GRIP B on the developing human fetus are unknown. There is an unknown...
- Hypersensitivity to 64Cu-GRIP B or any of its excipients.
See the full eligibility criteria
- Disease characteristics, as defined by:
- Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) with at least one prior line of therapy.
- Planned treatment with a commercially available CD19 targeting CAR-T cell product.
- Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion.
- Age \>= 18 years.
- Ability to understand and the willingness to sign a written informed consent document.
- Eastern Cooperative Oncology Group (ECOG) performance status \ 60%).
- Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is...
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
- Pregnant participants are excluded from this study because the effects of 64Cu-GRIP B on the developing human fetus are unknown. There is an unknown but potential risk for adverse events in nursing infants secondary to...
- Hypersensitivity to 64Cu-GRIP B or any of its excipients.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. 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.