CRMA-1001 IV gene therapy in adults with chronic hepatitis B
Official title: A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B
Run by nChroma Bio · NCT07200193 · Data updated 2026-11-12
This study will test whether intravenous CRMA-1001, an epigenetic gene therapy, is safe and shows antiviral activity in adults with chronic hepatitis B who remain on oral antivirals.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | nChroma Bio Industry-sponsored |
| Locations | 4 sites (Lyon and 3 other locations) |
| Status | Recruiting |
| Started | December 22, 2025 |
| Main results expected | December 31, 2032 |
| Study ends | December 31, 2032 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07200193 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–64 with chronic hepatitis B who are stable on oral antiviral therapy, have near-normal liver blood tests, and do not have significant fibrosis or other liver disease.
✕Probably not a fit
People with advanced fibrosis or cirrhosis, other non-HBV liver diseases, abnormal liver tests above protocol limits, or who fall outside the age/weight criteria are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label Phase 1/2 trial gives adults with chronic hepatitis B single or multiple intravenous doses of CRMA-1001 in escalating dose levels followed by a dose-expansion cohort. The primary goal is to determine safety and tolerability across up to four dose levels while participants continue their oral antiviral therapy. The study will also characterize pharmacokinetics, pharmacodynamics, and early signs of antiviral activity. Participants must meet liver-function limits and are excluded if they have significant fibrosis, cirrhosis, or other non-HBV liver disease.
Why it matters
Potential benefit: If successful, CRMA-1001 could provide a new way to lower HBV activity or alter viral gene expression beyond current antiviral pills.
How similar studies have gone: This epigenetic gene therapy approach for HBV is novel with limited clinical precedent, although other gene-silencing and immune-targeting HBV strategies have shown mixed early-stage signals.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male/Female, weight 45-150 kg, age 18-64, inclusive * Diagnosed with Chronic Hepatitis B * On oral antiviral therapy * ALT and AST \<= 1.5 x ULN * Total bilirubin \<= ULN Exclusion Criteria: * Significant hepatic fibrosis or cirrhosis * Current or prior liver disease other than HBV * Other protocol-defined inclusion/exclusion criteria may apply
Where it's running
-
Hospices Civils De Leon
Lyon, France Recruiting -
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong Recruiting -
New Zealand Clinical Research
Auckland, New Zealand Recruiting -
King's College Hospital
London, United Kingdom Recruiting
Study contacts
- Study coordinator: nChroma Bio
- Email: CRMA-1001-101-Study@nchromabio.com
- Phone: (617) 915 6203
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ACT201 Injection in Healthy People and in Chronic Hepatitis B Patients
This Phase 1 trial tests ACT201 against a placebo in healthy adults and in people with chronic hepatitis B who are on stable antiviral therapy to see if it is safe and how the body handles it.
-
Using hepatitis B immunoglobulin to boost lasting cure after peginterferon in chronic hepatitis B
This trial will test whether giving hepatitis B immunoglobulin to adults who cleared HBsAg after peginterferon helps them develop protective anti‑HBs antibodies and lowers the chance of relapse.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.