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RecruitingLast updated: 31 March 2025

This trial is recruiting people with relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukaemia (CLL) to evaluate the appropriate dose level, safety and effect of a new immunotherapy (called UB-VV111)A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

UB-VV111 is a type of immunotherapy called CAR T-cell therapy. CAR T-Cell therapy works by modifying immune cells (T-cells) so they more effectively target and attack cancer cells. UB-VV111 works by generating CAR T-cells in the participant's body which then bind to and destroy CD19+ cancer cells.

UB-VV111 will either be given as  a single dose by itself, or as a single dose followed by treatment with rapamycin.

 

Conditions

This trial is treating people with relapsed or refractory large B-cell lymphoma or chronic lymphocytic leukaemia that is CD19+

Eligibility

Inclusion

  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

  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 (except CAR T-cell therapy in CAR T-exposed subjects)
  4. History of or active human immunodeficiency virus (HIV)
  5. Active hepatitis B or C
  6. Systemic autoimmune or 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Umoja Biopharma

Scientific Title

A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies

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