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Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL

NCT04030195 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-01-31

Study results available
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Summary

This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.

Conditions

  • Non-Hodgkin's Lymphoma, Relapsed
  • Chronic Lymphoid Leukemia in Relapse
  • Non-Hodgkin's Lymphoma Refractory
  • Chronic Lymphocytic Leukemia
  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic
  • B-cell Chronic Lymphocytic Leukemia
  • B-cell Non Hodgkin Lymphoma
  • Small Lymphocytic Lymphoma

Interventions

GENETIC

PBCAR20A

Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.

DRUG

Fludarabine

Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).

DRUG

Cyclophosphamide

Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).

Sponsors & Collaborators

  • Precision BioSciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan List, MD · Precision BioSciences, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-24
Primary Completion
2021-06-24
Completion
2021-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04030195 on ClinicalTrials.gov