BridgeMD
New treatment option for Relapsed AL Amyloidosis
Official title A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
ClinicalTrials.gov ID: NCT07081646
What this study is testing
What is AZD0120?
AZD0120 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed al amyloidosis.
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
- Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
- Phase 2: a mid-size study of how well it works
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
- Confirmed histopathological diagnosis of AL amyloidosis
- One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
- Measurable hematologic disease: dFLC \> 20 mg/L or serum M-protein \> 5g/L
- Relapsed or refractory disease with a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
- ECOG performance status of 0 to 2
You likely can't join if
- Have any other form of amyloidosis other than AL amyloidosis
- Mayo Stage IIIb AL amyloidosis
- Oxygen saturation \< 95% on room air
- Systolic blood pressure \<100mmHg
- NYHA class III or IV
- Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator
See the full eligibility criteria
- Confirmed histopathological diagnosis of AL amyloidosis
- One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
- Measurable hematologic disease: dFLC \> 20 mg/L or serum M-protein \> 5g/L
- Relapsed or refractory disease with a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
- ECOG performance status of 0 to 2
- Must be able and willing to adhere to the study visit schedule and other protocol requirements
- Women of child-bearing potential (WCBP) must have a negative serum and/or urine pregnancy test result prior to treatment. All sexually active WCBP and all sexually active male people must agree to use highly effective...
- Have any other form of amyloidosis other than AL amyloidosis
- Mayo Stage IIIb AL amyloidosis
- Oxygen saturation \< 95% on room air
- Systolic blood pressure \<100mmHg
- NYHA class III or IV
- Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator
- Prior therapies:
- CAR T cell therapy directed at any target
- Prior BCMA-targeting therapy
- Prior treatment with any FDA approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months.
- Toxicity from previous anti-cancer or anti-PC-directed therapy did not resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
- Active plasma cell leukemia at the time of screening
- Symptomatic multiple myeloma (defined as clonal bone marrow plasma cells ≥10% plus at least one myeloma-defining event per IMWG 2014)
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
- London, United Kingdom
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 Phoenix, Arizona, United States; San Francisco, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States and 7 more location(s). 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.