A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmoja Biopharma

About this trial

This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Provides voluntary written informed consent

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

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

Disqualifiers

Women who are pregnant or breastfeeding

Current isolated central nervous system (CNS) involvement

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

History of or active human immunodeficiency virus (HIV)

Trial design

Design model

Sequential

Treatments tested in this trial

  • UB-VV111

    Genetic

    UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.

  • rapamycin

    Drug

    Rapamycin is an FDA-approved drug.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: UB-VV111Experimental treatment 1 intervention
Group B: UB-VV111 + rapamycinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with common adverse events (AEs)

Percentage of participants with commonly reported AEs overall and by severity

Time frame
Up to 2 years after UB-VV111 administration

Secondary outcomes

1

Overall response rate (ORR)

Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

Time frame
Up to 2 years after UB-VV111 administration

Other outcomes

Sponsors and contacts

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