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New treatment option for Relapsed/Refractory AL Amyloidosis
Official title Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
ClinicalTrials.gov ID: NCT07250269
What this study is testing
What is GC012F Injection?
GC012F Injection is an investigational medicine, being studied as a potential treatment for relapsed/refractory al amyloidosis.
Also referred to as AZD0120.
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 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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 disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
- ECOG performance status of 0 to 1
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
- Cardiac exclusion criteria:
- Mayo Stage IIIb AL amyloidosis (Wechalekar, 2013)
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 disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
- ECOG performance status of 0 to 1
- 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 pregnancy test prior to treatment. All sexually active WCBP and all sexually active male people must agree to use effective methods of birth control...
- 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
- Cardiac exclusion criteria:
- Mayo Stage IIIb AL amyloidosis (Wechalekar, 2013)
- NT-proBNP levels as follows: NT-proBNP ≥ 2000 ng/L (for dose escalation portion) NT-proBNP \ 5000 ng/L (for dose extension portion) c. High-sensitivity cardiac troponin T \> 75 ng/L d. NYHA class III or IV 5. Extensive...
- CAR T cell therapy directed at any target
- Prior BCMA-targeting therapy
- Prior treatment with any approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months. 7\. Toxicity from previous...
- Positive HBsAg, or
- Patients with positive core antibody (anti-HBc) and HBV-DNA positive.
- Patients with positive hepatitis C antibody and HCV RNA positive.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changchun, China
- Guangzhou, China
- Hangzhou, China
- Suzhou, China
- Wenzhou, China
- Wuhan, 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 Beijing, China; Changchun, China; Guangzhou, China; Hangzhou, China; Suzhou, China; Wenzhou, China and 1 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.