Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06209619

CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma

Led by Nathan Denlinger · Updated on 2026-02-27

18

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

N

Nathan Denlinger

Lead Sponsor

B

Bristol-Myers Squibb

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase I trial tests the safety, side effects and best dose of CC-99282 with rituximab for the treatment of patients who have received chimeric antigen receptor (CAR) T cell therapy for non-Hodgkins lymphoma and in whom have had a sub-optimal response early on to CAR T-cell therapy. Immunotherapy with CC-99282 may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving CC-99282 with rituximab may be a safe and effective treatment option for patients who have received CAR-T cell therapy for relapsed or refractory non-Hodgkin's lymphoma.

CONDITIONS

Official Title

CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent and HIPAA authorization
  • Aged 18 years or older at consent
  • Diagnosed with B-cell non-Hodgkin lymphoma, including large B-cell or follicular lymphoma subtypes
  • Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
  • Previously received CD19-directed CAR T-cell therapy (e.g., axicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel)
  • Pre-CAR T imaging within 90 days before CAR T infusion for baseline disease assessment
  • Evidence of objective response on PET/CT between 25 and 100 days after CAR T infusion
  • Sub-optimal response to CAR T defined by Deauville score of 3 or higher on PET/CT at 25-100 days post CAR T infusion
  • Absolute neutrophil count ≥ 7.5 x 10^8/L within 30 days before treatment start
  • Partial response with persistent minimal residual disease (MRD) positivity allowed
  • Hemoglobin ≥ 8 x 10^9/L within 30 days before treatment start
  • Platelets ≥ 50 x 10^9/L within 30 days before treatment start
  • Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min within 30 days before treatment start
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN), with exceptions for Gilbert's syndrome
  • AST and ALT ≤ 3 times ULN within 30 days before treatment
  • Ability to provide adequate tissue samples for MRD analysis
  • Corrected QT interval (QTcF) < 470 ms
  • Ability to swallow and absorb capsules
  • Females of childbearing potential must have a negative pregnancy test within 3 days before enrollment
  • Use of two effective contraception methods or complete abstinence required for females of childbearing potential
  • Male subjects with female partners must use condoms or abstain during and after treatment as specified
  • Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessments
  • Willing and able to comply with study procedures
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Uncontrolled illness such as severe heart failure, unstable angina, recent heart attack within 1 month, uncontrolled arrhythmias, seizures, or severe hypertension
  • Receipt of CAR T-cell therapy for indications other than specified in inclusion
  • Current use of strong CYP3A inhibitors or inducers without appropriate washout period
  • Use of other investigational agents including herbal supplements within 2 weeks or 5 half-lives prior to enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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