Clinical Trials for Sarcoma

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)

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.

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.

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

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.

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.

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

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.

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.

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

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.

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.

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

A Phase 2 Study of Atezolizumab With Selinexor in Alveolar Soft Part Sarcoma (AXIOM)

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.

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.

HealthScout AI summary: Single-arm study for adolescents and adults with unresectable/metastatic alveolar soft part sarcoma that has progressed on prior immune checkpoint inhibitor therapy, treating with atezolizumab (anti–PD-L1) plus selinexor (XPO1/CRM1 inhibitor). Includes a brief safety run-in in advanced STS NOS; treatment is atezolizumab IV every 28 days and selinexor orally on days 1, 8, 15 until progression or toxicity.

ClinicalTrials.gov ID: NCT05333458

A Phase 1/2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms

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.

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.

HealthScout AI summary: Adults with AML or high-grade myeloid neoplasms (≥10% blasts), including newly diagnosed adverse-risk disease (ELN 2022) and relapsed/refractory AML in phase I, receive intensive CLAG-M chemotherapy combined with venetoclax, an oral BCL‑2 inhibitor that promotes apoptosis. Induction includes G-CSF, cladribine, cytarabine, mitoxantrone plus venetoclax, with consolidation using CLAG (no mitoxantrone) plus venetoclax; key exclusions include APL, CML blast crisis, active CNS disease, uncontrolled infection, and need for strong CYP3A inhibitors (voriconazole allowed).

ClinicalTrials.gov ID: NCT04797767

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

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.

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.

HealthScout AI summary: Open-label, single-arm study of oral repotrectinib, a next-generation macrocyclic TKI targeting ROS1, ALK, and TRK (NTRK1/2/3) with CNS penetration, in children <12 with ALK/ROS1/NTRK-altered advanced malignancies (dose-finding) and adolescents/young adults (12–25) with NTRK fusion–positive (TKI-naïve or pretreated) or ROS1-altered advanced solid tumors/ALCL. Eligible patients require measurable disease and prior progression/intolerance or lack of standard therapy; endpoints include safety/PK in pediatrics and confirmed ORR by BICR in expansion cohorts.

ClinicalTrials.gov ID: NCT04094610

TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Soft Tissue Sarcoma

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.

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.

HealthScout AI summary: Adults with previously treated, locally advanced or metastatic leiomyosarcoma receive a metronomic regimen of trabectedin (DNA minor-groove binder affecting transcription/repair), gemcitabine (nucleoside analog), and dacarbazine (alkylating agent) on Days 1 and 8 of 21-day cycles. Single-arm study aims to assess disease control and tolerability as later-line therapy, treating until progression or toxicity for up to 1 year.

ClinicalTrials.gov ID: NCT04535271