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A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies

NCT05588440 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-12-05

Study results available
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Summary

This is a Phase 1/2 study to investigate the safety and efficacy of the CAR-T therapy, ONCT-808, in patients with relapsed/refractory (R/R) aggressive B cell malignancies.

Conditions

  • Relapsed/Refractory Aggressive B-Cell Malignancies

Interventions

BIOLOGICAL

ONCT-808

A single infusion of ONCT-808 autologous CAR-T cell infusion will be administered intravenously Phase 1: Dose Escalation with bridging therapy as needed Phase 2: Patients with LBCL or MCL will be enrolled into two separate dose expansion cohorts.

DRUG

Bridging Therapy

Bridging therapy can be oral chemotherapy or IV radiotherapy/chemotherapy per institution's guidelines

Sponsors & Collaborators

  • Oncternal Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Michael Wang · MD Anderson

  • Matthew Wei · City of Hope Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2024-09-12
Completion
2024-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588440 on ClinicalTrials.gov