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Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy

NCT05352828 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-04-03

No results posted yet for this study

Summary

This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients aged 12 years of age and above with relapsed or refractory classical Hodgkin lymphoma (cHL) following failure of standard frontline therapy.

Conditions

  • Classical Hodgkin Lymphoma
  • Hodgkin Disease Refractory
  • Hodgkin Disease Recurrent

Interventions

DRUG

Nivolumab

Dose: 480 mg or 6 mg/kg Q4W

DRUG

Autologous CD30.CAR-T

Dose: 2 x 10e8 cells/m2

DRUG

Fludarabine

Dose: 30 mg/m2/day x 3 days

DRUG

Bendamustine

Dose: 70 mg/m2/day x 3 days

Sponsors & Collaborators

Principal Investigators

  • Helen Heslop, MD · Baylor College of Medicine

  • Sairah Ahmed, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2025-12-15
Completion
2037-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT05352828 on ClinicalTrials.gov