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Not yet recruitingPhase 1

BLinatumomab and iNKT in Relapsed B-Cell ALL

BLINKB-ALL: BLinatumomab and iNKT in Relapsed B-Cell ALL

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests agenT-797, an immune cell treatment, with blinatumomab in adults with B-cell acute lymphoblastic leukemia (B-ALL), a blood cancer. It is for people whose cancer has worsened or returned, or whose tests show small amounts of cancer again after none were found. The study mainly checks safety and side effects, and also looks at how well the treatment works.

This is an open-label, single-arm pilot study evaluating agenT-797, an invariant natural killer T-cell (iNKT) therapy, in combination with routine clinical care blinatumomab in subjects with Philadelphia chromosome-negative, CD19-positive B-cell acute lymphoblastic leukemia (B-ALL), who have experienced disease progression while receiving blinatumomab, become measurable residual disease (MRD)-positive following prior MRD negativity, or have relapsed disease. The primary objective of this study is to assess safety and tolerability of the first planned dose of agenT-797 in combination with blinatumomab. Secondary objectives include evaluating the efficacy of combination therapy and other predefined secondary endpoints. Up to 13 subjects will be enrolled in this study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have B-cell ALL.
  • Have tests show small amounts of cancer again after none were found, or have cancer return during or after blinatumomab treatment.
  • Sign a consent form to join and allow the release of personal health information.
  • Be willing and able to follow study steps, as judged by the study team.

Who can't join

  • Cancer cells no longer have CD19, a marker on their surface.
  • Have active leukemia in the brain or spinal cord classified as CNS 3.
  • Have an infection that is not under control.
  • Have Philadelphia chromosome-positive leukemia, which has a specific gene change.
  • Be receiving another treatment aimed at leukemia at the same time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. * Age ≥ 18 years. * Diagnosis of B-cell ALL. * Detection of new MRD positivity after prior MRD negativity, or frank relapse while receiving or after blinatumomab. MRD positivity will be assessed by multiparameter flow Exclusion Criteria: * Loss of CD19 expressions. * Participants with active CNS 3 disease (central nervous system leukemia involvement) * Uncontrolled infection * Philadelphia positive disease (9;22 translocation at location of BCR-ABL1 fusion) * Other concurrent leukemia-directed therapy

Study sites (1)

NC