GC012F CAR-T therapy for relapsed or refractory AL amyloidosis in Chinese adults
Tests GC012F, a CAR-T cell therapy, in adults whose AL amyloidosis returned or resisted treatment.
Plain-language title generated from the registry record
Registry title: Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
Key facts
- Where
- Beijing, Changchun, Guangzhou, Hangzhou, Suzhou, Wenzhou, and Wuhan, ChinaSee the 7 sites
- Phase
- Phase 1
Where in China
- BeijingBeijing, ChinaTaking people
- ChangchunChangchun, ChinaTaking people
- GuangzhouGuangzhou, ChinaTaking people
- HangzhouHangzhou, ChinaTaking people
- SuzhouSuzhou, ChinaTaking people
- WenzhouWenzhou, ChinaTaking people
- WuhanWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Trial code
- NCT07250269
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 1b Study of GC012F, a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B-cell Maturation Antigen in Chinese Participants With Relapsed or Refractory AL Amyloidosis
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.
Inclusion: 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 subjects must agree to use effective methods of birth control throughout the study.
Exclusion: Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator 6. Prior therapies:; 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; 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; Cardiac exclusion criteria:; Mayo Stage IIIb AL amyloidosis as defined by; NT-proBNP>8500ng/L, and; high sensitivity cardiac troponin T ≥ 50 ng/L cardiac Troponin T ≥ 0.035 ng/mL or cardiac Troponin I ≥ 0.1 ng/mL; NT-proBNP levels as follows:; NT-proBNP ≥ 2000 ng/L (for dose escalation portion); NT-proBNP < 2000 and > 8500 ng/L (for dose extension portion); NYHA class III or IV; Active plasma cell leukemia at the time of screening 9. Multiple myeloma defined as clonal bone marrow PCs ≥10% and any one or more of the following myeloma defining events (deemed as attributable to multiple myeloma by Investigator) 10. Seropositive for HIV 11. Serologic status reflecting active hepatitis B or C:; Patients with positive core antibody (anti-HBc) and HBV-DNA positive; Patients with positive hepatitis C antibody and HCV RNA positive; 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; Positive HBsAg, or.