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NCT03512405
Pembrolizumab and Blinatumomab in Treating Participants With Recurrent or Refractory Acute Lymphoblastic Leukemia
Active, enrolled
Phase 1, PHASE2
Last updated 30 May 2025
What this trial tests
Phase 1, PHASE2 trial testing Blinatumomab in CD19 Positive in 36 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
2 August 2019
Primary endpoint
11 November 2025
11 November 2025
11 November 2025
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 2 August 2019 |
| Primary completion | 11 November 2025 |
| Estimated completion | 11 November 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Blinatumomab (blinatumomab) — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- CD19 Positive — all drugs for CD19 Positive →
- Philadelphia Chromosome Positive — all drugs for Philadelphia Chromosome Positive →
- Recurrent Acute Lymphoblastic Leukemia — all drugs for Recurrent Acute Lymphoblastic Leukemia →
- Refractory Acute Lymphoblastic Leukemia — all drugs for Refractory Acute Lymphoblastic Leukemia →
Sponsor
City of Hope Medical Center
Who can join
18 and older, any sex, with CD19 Positive or Philadelphia Chromosome Positive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I/II studies the side effects of pembrolizumab and blinatumomab and to see how well they work in treating participants with acute lymphoblastic leukemia that has come back or has not responded to the treatment. Monoclonal antibodies, such as pembrolizumab and blinatumomab, may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The landscape of bispecific T cell engager in cancer treatment.
Zhou S, Liu M, Ren F, Meng X, et al · · 2021 · cited 172× · PMID 34039409 · DOI 10.1186/s40364-021-00294-9 -
Overcoming the challenges associated with CD3+ T-cell redirection in cancer.
Singh A, Dees S, Grewal IS. · · 2021 · cited 82× · PMID 33469153 · DOI 10.1038/s41416-020-01225-5 -
Bispecific, T-Cell-Recruiting Antibodies in B-Cell Malignancies.
Lejeune M, Köse MC, Duray E, Einsele H, et al · · 2020 · cited 70× · PMID 32457743 · DOI 10.3389/fimmu.2020.00762 -
Blinatumomab maintenance after allogeneic hematopoietic cell transplantation for B-lineage acute lymphoblastic leukemia.
Gaballa MR, Banerjee P, Milton DR, Jiang X, et al · · 2022 · cited 67× · PMID 34914826 · DOI 10.1182/blood.2021013290 -
Blinatumomab, a bispecific B-cell and T-cell engaging antibody, in the treatment of B-cell malignancies.
Burt R, Warcel D, Fielding AK. · · 2019 · cited 51× · PMID 30380973 · DOI 10.1080/21645515.2018.1540828 -
Blinatumomab for the Treatment of Adult B-Cell Acute Lymphoblastic Leukemia: Toward a New Era of Targeted Immunotherapy.
Franquiz MJ, Short NJ. · · 2020 · cited 38× · PMID 32103893 · DOI 10.2147/btt.s202746 -
Concepts in immuno-oncology: tackling B cell malignancies with CD19-directed bispecific T cell engager therapies.
Viardot A, Locatelli F, Stieglmaier J, Zaman F, et al · · 2020 · cited 31× · PMID 32856140 · DOI 10.1007/s00277-020-04221-0 -
Stepping forward: T-cell redirecting bispecific antibodies in cancer therapy.
Qin X, Ning W, Liu H, Liu X, et al · · 2024 · cited 28× · PMID 38828136 · DOI 10.1016/j.apsb.2024.03.027
Verify or expand the search:
- PubMed search for NCT03512405
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Blinatumomab
Trials testing the same drug.
- NCT07192237 — Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Diseas · Phase 2 · not yet recruiting
- NCT07178912 — Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromoso · Phase 2 · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
- NCT06991920 — Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage · NA · not yet recruiting
- NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
Other recruiting trials for CD19 Positive
Currently open trials in the same condition.
- NCT04007029 — Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chron · Phase 1 · active not recruiting
- NCT03241940 — Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults w/ Recurrent or Refractory B Cel · Phase 1 · active not recruiting
- NCT03233854 — CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell · Phase 1 · active not recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
- NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03512405 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
- Last refreshed: 30 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03512405.
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