New combo therapy shows promise for relapsed leukemia
NCT ID NCT03160079
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a combination of two drugs—blinatumomab and pembrolizumab—in 16 adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who had high levels of cancer cells in their bone marrow. The goal was to see if adding pembrolizumab to blinatumomab could improve the rate of complete remission (no detectable cancer). The study is complete, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- blinatumomab and pembrolizumab
- What this could lead to
- If successful, this combination could improve remission rates for adults with hard-to-treat B-cell acute lymphoblastic leukemia.
- What could go wrong
- This is an early-phase, small trial (16 participants) with no control group, so results may not be conclusive. The drugs can cause serious side effects like infections or immune reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
16 people
The number who actually took part.
- Started
-
Aug 2017
- Finished
-
Jun 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL) having received at least 1 prior line of therapy * Philadelphia chromosome positive (Ph+), or Breakpoint Cluster Region Protein-Abelson Murine Leukemia Viral Oncogene Homolog 1 (BCR-ABL1) positive B-lineage ALL must have failed at least 1 second or third generation tyrosine kinase inhibitor (TKI) or be intolerant to TKIs * Greater than 50% lymphoblasts on screening bone marrow aspirate or biopsy * Adequate organ function * Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: * Allogeneic hematopoietic cell transplantation within 5 years of study drug administration * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) or Granulocyte Colony-Stimulating Factor (G-CSF) use within 2 weeks of study treatment and throughout the study * Prior checkpoint inhibitor therapy including anti Programmed Death Receptor 1 (anti-PD1), anti-PD-L1, anti-CTLA4 (cytotoxic T-lymphocyte-associated protein 4), anti tumor necrosis factor receptor superfamily, member 9 (anti-CD137), or anti-PD-L2 therapy * Active Central Nervous System (CNS) or testicular involvement by leukemia * History of neurologic disorder * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Burkitt lymphoma/leukemia * Has a diagnosis of congenital immunodeficiency * Has a known history of active Bacillus Tuberculosis (TB) * Known Human Immunodeficiency Virus (HIV) infection * Active hepatitis B or hepatitis C infection * Has received a live vaccine within 30 days prior to first dose * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * History of autoimmune disease * Known interstitial lung disease * Any evidence of active, non-infectious pneumonitis or has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis * Patients who have received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 2 weeks earlier. * Patients who are less than 4 weeks from surgery or have insufficient recovery from surgical-related trauma or wound healing. * Known impaired cardiac function
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell acute lymphoblastic leukemia, adult are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
-
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
-
UCSF Comprehensive Cancer Center
San Francisco, California, 94143, United States
-
UCSF Fresno Community Cancer Institute
Clovis, California, 93611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Engineered immune cells take aim at Hard-to-Treat leukemia
- Engineered immune cells take aim at Hard-to-Treat childhood leukemia
- Supercharged immune cells take on tough B-Cell cancers in early trial
- New drug combo shows promise for tough leukemia cases
- Engineered immune cells take on childhood blood cancers in early trial
- Experimental CAR t therapy targets tough leukemia in first human trial