A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies

NCT07735533
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
274
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Lead sponsor
Umoja Biopharma
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Start date
2026-09-01
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Number of sites
1
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Summary
This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).
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Short title
A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
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Official title
A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2031-08-01
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First posted
2026-07-30
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Registry last updated
2026-10-09
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Primary completion date
2031-08-01
clinicaltrials.gov
Start date
2026-09-01
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Participants
274
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Participant count basis
Estimated
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Planned participants
274
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Umoja Biopharma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07735533
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ClinicalTrials.gov ID
NCT07735533
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Registry record
Open registry record
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Allocation
Not applicable
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Phase 1: Percentage of participants with common adverse events (AEs)

    Timeframe: Up to 2 years after UB-VV400 administration

    Percentage of participants with commonly reported AEs overall and by severity

  2. Phase 2: Overall response rate (ORR)

    Timeframe: Up to 2 years after UB-VV4001 administration

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

  1. Phase 1: Overall response rate (ORR)

    Timeframe: Up to 2 years after UB-VV400 administration

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

  2. Phase 1 and Phase 2: Complete response rate (CRR)

    Timeframe: Up to 2 years after UB-VV400 administration

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

  3. Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400

    Timeframe: Up to 8 days after UB-VV400 administration

    Maximum concentration (Cmax), time to maximum concentration (Tmax), and AUC (area under the concentration vs time curve) for UB-VV400

  4. Phase 2: Percentage of participants with common AEs

    Timeframe: Up to 2 years after UB-VV111 administration

    Percentage of participants with commonly reported AEs overall and by severity

  5. Phase 2: Duration of response (DOR)

    Timeframe: Up to 2 years after UB-VV400 administration

    Duration from first evidence of response (CR or PR) to date of first evidence of disease progression or death, whichever is earlier

  6. Phase 2: Progression-free survival (PFS)

    Timeframe: Up to 2 years after UB-VV400 administration

    Duration from first administration of UB-VV400 to the first evidence of disease progression or death from any cause, whichever is earlier.

  7. Phase 2: Overall survival (OS)

    Timeframe: Up to 2 years after UB-VV400 administration

    Duration from first administration of UB-VV400 to death from any cause

  8. Phase 2: Quality of life (QOL)

    Timeframe: Up to 2 years after UB-VV400 administration

    Performance on 2 QoL scales: EuroQol instrument EQ-5D-5L and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. 18 years or older
  2. Provides voluntary written informed consent
  3. Relapsed or refractory large B-cell lymphoma (LBCL)
  4. Measurable disease according to Lugano 2014 criteria
  5. Confirmed CD22 expression
  6. No serious concomitant diseases or active/uncontrolled infections
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  8. Adequate organ function

  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 tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
  4. History of or active human immunodeficiency virus (HIV)
  5. Active or chronic hepatitis B, or active hepatitis 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.
Sources for eligibility
clinicaltrials.gov

  • Sarah Cannon Research InstituteNashville, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (1)