Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis

NCT07250269 | Recruiting Phase 1

• 2 other identifiers: D831AC00002AZD0120-AL-202
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 9

Brief Summary

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

Relapsed/Refractory AL Amyloidosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With incidence and severity of Treatment-emergent Adverse Events

  Through study completion, an average of 2 years

• Proportion of Participants Experiencing a Complete Response

  Through study completion, an average of 2 years

Secondary Outcomes (2)

• Levels of AZD0120 in blood over time in participants with AL amyloidosis

  Through study completion, an average of 2 years

• Percentage of participants achieving hematologic response

  Through study completion, an average of 2 years

Study Arms (1)

GC012F

EXPERIMENTAL

GC012F Injection

Drug: GC012F Injection

Interventions

GC012F Injection DRUG

The investigational agent, GC012F, is an autologous BCMA/CD19 dual directed CAR product under investigation for the treatment of patients with RRMM, ELMM, SLE, and B NHL.

Also known as: AZD0120

GC012F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify 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
• Mayo Stage IIIb AL amyloidosis (Wechalekar, 2013)
• NT-proBNP levels as follows:
• NT-proBNP ≥ 2000 ng/L (for dose escalation portion) NT-proBNP \< 2000 and \> 5000 ng/L (for dose extension portion) c. High-sensitivity cardiac troponin T \> 75 ng/L d. NYHA class III or IV 5. 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.
• \. 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) (Rajkumar, 2014) 10. Seropositive for HIV 11. Serologic status reflecting active hepatitis B or C:
• Positive HBsAg, or
• Patients with positive core antibody (anti-HBc) and HBV-DNA positive.
• Patients with positive hepatitis C antibody and HCV RNA positive.

Sponsors & Collaborators

• Gracell Biotechnologies (Shanghai) Co., Ltd.: lead
• Suzhou Gracell Biotechnologies Co., Ltd.: collaborator

Study Sites (9)

Research Site

Beijing, 100034, China

RECRUITING

Research Site

Beijing, 100070, China

RECRUITING

Research Site

Beijing, CN-100730, China

RECRUITING

Research Site

Changchun, 130021, China

RECRUITING

Research Site

Guangzhou, 510100, China

RECRUITING

Research Site

Hangzhou, 310003, China

NOT YET RECRUITING

Research Site

Suzhou, 215006, China

RECRUITING

Research Site

Wenzhou, 325000, China

RECRUITING

Research Site

Wuhan, 430022, China

NOT YET RECRUITING

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: November 26, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): November 24, 2028
• Study Completion (Estimated): November 24, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CN (9)