A Phase I Trial of Donor- Derived 19-28z CAR T Cells Following Allogeneic Transplant for the Treatment of CD19 Malignancies

NCT04556266 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 17-331
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purposed of this study is to determine whether an infusion with specialized 'modified T cells' (or CD19 chimeric antigen T cells, also called CD19 CAR T cells) that target the B cell marker will reduce the risk of relapse after transplant.

Conditions

Leukemia; Lymphoma; Lymphoma, B-Cell

Keywords

Leukemia; Lymphoma; Lymphoma, B-Cell; Chimeric Antigen Receptor (CAR) T cells; CART cells; high-risk B-cell malignancies; 17-331; Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  To determine maximum tolerated dose (MTD) of intravenously administered allogeneic, donor-derived 19-28z CAR T cells administered following TCD allo-HSCT for patients with high-risk CD19+ malignancies

  24 month

Study Arms (4)

Cohort -1

EXPERIMENTAL

Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT Total T-Cell Dose: 1 x 10\^4 cells/kg

Biological: CAR T-Cell Infusion

Cohort 1

EXPERIMENTAL

Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT Total T-Cell Dose: 1 x 10\^5 cells/kg

Biological: CAR T-Cell Infusion

Cohort II

EXPERIMENTAL

Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT Total T-Cell Dose: 2 x 10\^5 cells/kg

Biological: CAR T-Cell Infusion

Cohort III

EXPERIMENTAL

Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT Total T-Cell Dose: 4 x 10\^5 cells/kg

Biological: CAR T-Cell Infusion

Interventions

CAR T-Cell Infusion BIOLOGICAL

Dose Level -1: 1 x 10\^4 cells/kg Dose Level 1: 1 x 10\^5 cells/kg Dose Level 2: 2 x 10\^5 cells/kg Dose Level 3: 4 x 10\^5 cells/kg

Cohort -1; Cohort 1; Cohort II; Cohort III

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The following criteria must be met prior to the allogenic transplantation:
• ALL in second remission or greater (≥ CR2)
• Please refer to section 3.0 for more discussion of ALL in CR1 versus CR2
• CLL
• High risk in any remission status as defined by 17p deletion or Richter's transformation, or
• All other patients eligible after at least 2 lines of standard or investigational chemotherapy
• B-NHL
• Refractory or stable disease to last line of therapy per ICML 2014. Patients should have at least 2 lines of prior therapy.
• Relapsed disease in patients who are not candidates for autologous transplant
• Patient's age is ≥ 18 and ≤ 60.
• KPS ≥ 70%
• Patients must have CD19 expression (by any detection method) demonstrated on their malignant cells at the time of enrollment on the protocol.
• Patients relapsed after prior CD19 CAR T cell or blinatumomab are eligible for enrollment as long as CD19 expression is still prese on the malignant cells.
• Patients who have a matched related donor willing to donate HSC for allograft and PBMC for CAR T cell generation
• Patients must have adequate organ function measured by:

You may not qualify if:

• Active and uncontrolled infection at time of transplantation. Please note that patients being actively treated for a viral reactivation may be enrolled on the protocol at the discretion of the investigators.
• Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
• Pregnant or breast feeding
• HIV infection
• Progressive disease at time of transplant
• Patients with known autoimmune disease.
• Patients with active or clinically significant neurological disorders, such as seizure disorders.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia; Lymphoma; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Study Officials

• Miguel-Angel Perales, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: July 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 13, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)