Clinical Trials for Sarcoma

SAINT: A Phase 1/2 Study of Safe Amounts of IPLIMUMAB, NIVOLUMAB and TRABECTEDIN for Previously Treated Advanced Soft Tissue Sarcoma (STS)

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with previously treated, unresectable or metastatic soft tissue sarcoma (ECOG 0–1) receive trabectedin (24‑hr IV q3wk at MTD) combined with fixed-dose ipilimumab (CTLA‑4 inhibitor) and nivolumab (PD‑1 inhibitor) to assess safety and preliminary efficacy. Excludes active autoimmune disease, untreated CNS metastases, significant immunosuppression, and active hepatitis B/C or HIV.

ClinicalTrials.gov ID: NCT03138161

Evolutionary Inspired Therapy for Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Newly diagnosed metastatic PAX/FOXO1 fusion–positive rhabdomyosarcoma (children to adults) treated with standard cytotoxic regimens using alternative scheduling strategies: VAC-based “first strike” (vinorelbine/actinomycin D/cyclophosphamide), “second strike” with prolonged vinorelbine + oral cyclophosphamide maintenance after VAC response, adaptive therapy with response-guided intermittent VAC, or conventional 42-week VAC±irinotecan/doxorubicin/ifosfamide/etoposide. No novel agents; compares front-loaded, maintenance, and adaptive timing of standard chemotherapy to optimize EFS/OS with acceptable toxicity.

ClinicalTrials.gov ID: NCT04388839

Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adolescents and young adults (12–49 years, ≥40 kg) with relapsed/refractory sarcomas—Phase 2 cohorts for Ewing sarcoma (FET-ETS fusion), DSRCT (EWSR1::WT1), and an “other sarcoma” cohort (including RMS, osteosarcoma, and other translocation-associated round cell sarcomas)—receive PEEL-224 plus vincristine and temozolomide on 21-day cycles with growth factor support. PEEL-224 is an investigational PEGylated topoisomerase I inhibitor prodrug (PEG-[SN22]4) designed to release SN22 and overcome common camptothecin resistance mechanisms; CNS metastases are excluded for EWS/DSRCT cohorts.

ClinicalTrials.gov ID: NCT06709495

A Phase I Study of Pomalidomide and Nivolumab in Patients With Virus-Associated Malignancies With or Without HIV

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with relapsed/refractory or non-curable virus-associated malignancies (including EBV-, HPV-, HBV/HCV-, MCPyV-, and KSHV-associated cancers; HIV-positive allowed on suppressive ART) receive nivolumab (PD-1 inhibitor) plus oral pomalidomide (IMiD enhancing T/NK/dendritic-cell function) in 28-day cycles. Designed to establish safety/MTD and explore activity, with expansion cohorts enriched for Kaposi sarcoma and EBV/KSHV-associated lymphomas.

ClinicalTrials.gov ID: NCT04902443

Phase I/Ib Study of Adoptive NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Reactive Against the NY-ESO-1-specific Cord Blood-derived NK Cells (NY-ESO-1 TCR/IL-15 NK) in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: HLA-A*02:01/02:05/02:06–positive adolescents/adults with NY‑ESO‑1–expressing (≥50% by IHC) advanced synovial sarcoma or myxoid/round cell liposarcoma (post ≥1 line; prior doxorubicin/ifosfamide ± trabectedin as indicated) receive fludarabine/cyclophosphamide lymphodepletion followed by a single infusion of allogeneic cord blood–derived NK cells engineered with an affinity‑enhanced NY‑ESO‑1–specific TCR and IL‑15. Investigational product targets NY‑ESO‑1 peptides in HLA‑A*02 context while retaining innate NK activity; dose‑escalation with disease‑specific expansion.

ClinicalTrials.gov ID: NCT06083883

Interleukin-15 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as Immunotherapy for Patients With SOLID TUMORS (CATCH)

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with relapsed/refractory GPC3-positive solid tumors (including HCC meeting BCLC A–C and Child-Pugh <7) receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous GPC3-targeted CAR T cells engineered to express IL-15 for enhanced persistence and an inducible caspase-9 safety switch. Key exclusions include prior organ transplant, uncontrolled infection, HIV, pregnancy, high-dose steroids at infusion, and murine protein hypersensitivity/HAMA.

ClinicalTrials.gov ID: NCT05103631

Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transformed Follicular Lymphomas

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with relapsed/refractory DLBCL or transformed FL (including FL3B) who have measurable disease after CD19-directed CAR T and no standard options receive early post–CAR T CD20×CD3 bispecific therapy: either mosunetuzumab or obinutuzumab lead-in followed by glofitamab. Both agents redirect T cells to CD20+ B cells (bispecific T-cell engagers) to provide dual targeting after CD19 CAR T failure; key exclusions include significant prior CAR T–related CRS/ICANS and active infections.

ClinicalTrials.gov ID: NCT04889716

Phase I Study of EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Pediatric and young adult patients (ages 1–30) with relapsed/refractory, EGFR-expressing non-CNS solid tumors receive a single infusion of autologous CAR T cells targeting the EGFR806 conformational epitope (4-1BBζ; with EGFRt suicide marker), with a second arm co-expressing an added CD19 CAR (4-1BBζ; HER2tG suicide marker) to enhance expansion/persistence. Key aims are to assess safety, dose, feasibility, and CAR persistence; lymphodepletion specifics not described.

ClinicalTrials.gov ID: NCT03618381

A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with relapsed/refractory B‑cell non‑Hodgkin lymphoma (any subtype) after ≥2 prior therapies, including those previously treated with CD19 CAR T or ineligible for it, receive a single IV infusion of SynKIR‑310, an autologous CD19‑directed KIR‑CAR T‑cell therapy using a multichain KIR/DAP12 signaling platform designed to enhance persistence and antitumor activity. Includes post‑auto/allo transplant patients (with restrictions) and requires measurable disease and ECOG 0–1.

ClinicalTrials.gov ID: NCT06544265

A Phase I Study of Vorinostat in Combination With Vincristine, Irinotecan, and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors and CNS Malignancies

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Relapsed/refractory pediatric, adolescent, and young adult patients (≤30 years) with histologically confirmed solid tumors or CNS malignancies receive vincristine/irinotecan/temozolomide (VIT), with vorinostat added from cycle 2 onward in a dose-escalation schema. Vorinostat is an oral histone deacetylase (HDAC) inhibitor intended to enhance DNA-damaging chemotherapy sensitivity; trial defines its tolerated dose with VIT and assesses preliminary activity.

ClinicalTrials.gov ID: NCT04308330