Phase 1 study

Recruiting Phase 1

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 1
Sponsor Umoja Biopharma
Registry number NCT06528301
Started 10 March 2025 Today 16 October 2026 Estimated completion 1 March 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal North Shore Hospital Saint Leonards NSW Recruiting
St. Vincent's Hospital Melbourne Fitzroy VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 106

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

1. 18 years or older

2. Provides voluntary written informed consent

3. Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)

4. Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).

5. No serious concomitant diseases or active/uncontrolled infections

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

7. Adequate organ function

8. Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding

2. Current isolated central nervous system (CNS) involvement

3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells)

4. History of or active human immunodeficiency virus (HIV)

5. Active hepatitis B or C

6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease

7. Ongoing CNS disease that would preclude neurologic assessment

8. Uncontrolled angina or other acute heart disease

9. Currently receiving treatment in another interventional clinical trial.

Dates on the record

Started 10 March 2025
Estimated completion 1 March 2029
Registry last updated 15 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 15 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.