CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

Conditions

• Diffuse Midline Glioma, H3 K27-Altered
• Metastatic Malignant Neoplasm in the Central Nervous System
• Recurrent Diffuse Intrinsic Pontine Glioma
• Recurrent Diffuse Midline Glioma, H3 K27-Altered
• Recurrent Lymphoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Primary Malignant Central Nervous System Neoplasm
• Refractory Lymphoma
• Refractory Malignant Solid Neoplasm
• Refractory Primary Malignant Central Nervous System Neoplasm

Eligibility Criteria

Sex

ALL

Age

12 Months - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Bone Marrow Aspirate — PROCEDURE
  Undergo bone marrow aspirate
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• FACT Complex-targeting Curaxin CBL0137 — DRUG
  Given IV

Study Details

This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.

Key Dates

Start date

Jan 28, 2022

Status verified

Sep 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

63 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (CBL0137)
  Patients receive CBL0137 IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients with pseudoprogression may remain on treatment, as per the treating physician. Patients also undergo ECHO collection of blood samples throughout the trial. Patients may also undergo bone marrow aspirate and/or biopsy as clinically indicated.

Primary Outcome Measure

Maximum tolerated dose and/or Recommended Phase 2 dose of CBL0137 [ Time Frame: Up to 21 days ]

Locations (34)

Find similar trials in Birmingham, AL

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