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CD19-Specific T Cells Post AlloSCT

NCT03579888 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-06-02

No results posted yet for this study

Summary

This phase I trial investigates the side effects and best dose of CD19 positive (+) specific CAR-T cells in treating patients with CD19+ lymphoid malignancies, such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, small lymphocytic lymphoma, or chronic lymphocytic lymphoma. Sometimes researchers change the genetic material in the cells of a patient's T cells using a process called gene transfer. Researchers then inject the changed T-cells into the patient's body. Receiving the T-cell infusion may help to control the disease.

Conditions

  • B Acute Lymphoblastic Leukemia With t(v;11q23.3); KMT2A Rearranged
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Ph-Like Acute Lymphoblastic Leukemia
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Mantle Cell Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Ph-Like Acute Lymphoblastic Leukemia
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Refractory Small Lymphocytic Lymphoma

Interventions

BIOLOGICAL

Autologous CD19-CD8-CD28-CD3zeta-CAR-mbIL15-HER1t T Cells

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

Sponsors & Collaborators

  • Ziopharm Oncology

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Partow Kebriaei · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2021-05-27
Completion
2021-05-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03579888 on ClinicalTrials.gov