Actively Recruiting
Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
Led by Gracell Biotechnologies (Shanghai) Co., Ltd. · Updated on 2026-04-28
9
Participants Needed
9
Research Sites
160 weeks
Total Duration
On this page
Sponsors
G
Gracell Biotechnologies (Shanghai) Co., Ltd.
Lead Sponsor
S
Suzhou Gracell Biotechnologies Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of AL amyloidosis by tissue biopsy
- One or more organs affected by AL amyloidosis currently or in the past
- Measurable hematologic disease with dFLC > 20 mg/L or serum M-protein > 5 g/L
- Relapsed or refractory disease needing additional therapy after at least one prior anti-plasma cell therapy
- ECOG performance status 0 to 1
- Ability and willingness to follow study visit schedule and protocol requirements
- Women of child-bearing potential must have a negative pregnancy test before treatment and agree to use effective birth control; sexually active male participants must also agree to use birth control during the study
You will not qualify if you...
- Diagnosis of amyloidosis other than AL amyloidosis
- Mayo Stage IIIb AL amyloidosis
- Oxygen saturation less than 95% on room air
- Systolic blood pressure less than 100 mmHg
- Cardiac conditions including Mayo Stage IIIb AL amyloidosis, NT-proBNP levels above specified thresholds, high-sensitivity cardiac troponin T above 75 ng/L, or NYHA class III or IV heart failure
- Extensive gastrointestinal involvement with active bleeding or bleeding risk
- Prior CAR T cell therapy targeting any antigen
- Prior BCMA-targeting therapy
- Treatment with any approved or investigational T cell engaging therapies within the last 6 months
- Unresolved toxicity from previous cancer therapy above Grade 1 except alopecia or peripheral neuropathy
- Active plasma cell leukemia at screening
- Multiple myeloma with clonal bone marrow plasma cells ≥10% plus associated myeloma-defining events
- HIV positive
- Active hepatitis B or C infection based on serologic and DNA/RNA tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Research Site
Beijing, China, 100034
Actively Recruiting
2
Research Site
Beijing, China, 100070
Actively Recruiting
3
Research Site
Beijing, China, CN-100730
Actively Recruiting
4
Research Site
Changchun, China, 130021
Actively Recruiting
5
Research Site
Guangzhou, China, 510100
Actively Recruiting
6
Research Site
Hangzhou, China, 310003
Not Yet Recruiting
7
Research Site
Suzhou, China, 215006
Actively Recruiting
8
Research Site
Wenzhou, China, 325000
Actively Recruiting
9
Research Site
Wuhan, China, 430022
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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