NCT03690011

Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells

Recruiting now Phase 1 Last updated 23 October 2025

What this trial tests

Phase 1 trial testing CD7.CAR/28zeta CAR T cells in T-cell Acute Lymphoblastic Lymphoma in 27 participants. Currently enrolling.

Timeline

2 August 2021

Primary endpoint
1 May 2026

1 May 2040

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	2 August 2021
Primary completion	1 May 2026
Estimated completion	1 May 2040
Sites	2 locations across United States

Drugs / interventions tested

• CD7.CAR/28zeta CAR T cells

Conditions studied

• T-cell Acute Lymphoblastic Lymphoma — all drugs for T-cell Acute Lymphoblastic Lymphoma →
• T-non-Hodgkin Lymphoma — all drugs for T-non-Hodgkin Lymphoma →
• T-cell Acute Lymphoblastic Leukemia — all drugs for T-cell Acute Lymphoblastic Leukemia →

Sponsor

Baylor College of Medicine

Who can join

Under 75, any sex, with T-cell Acute Lymphoblastic Lymphoma or T-non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer).

The body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat cancer; they have shown promise, but have not been strong enough to cure most patients.

T cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.

The antibody used in this study is called anti-CD7. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor.

In the laboratory, investigators have also found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells.

In this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Applications of genome editing technology in the targeted therapy of human diseases: mechanisms, advances and prospects.
   Li H, Yang Y, Hong W, Huang M, et al · · 2020 · cited 733× · PMID 32296011 · DOI 10.1038/s41392-019-0089-y
2. CRISPR-Based Therapeutic Genome Editing: Strategies and In Vivo Delivery by AAV Vectors.
   Wang D, Zhang F, Gao G. · · 2020 · cited 405× · PMID 32243786 · DOI 10.1016/j.cell.2020.03.023
3. CRISPR Gene Therapy: Applications, Limitations, and Implications for the Future.
   Uddin F, Rudin CM, Sen T. · · 2020 · cited 329× · PMID 32850447 · DOI 10.3389/fonc.2020.01387
4. Engineered T Cell Therapy for Cancer in the Clinic.
   Zhao L, Cao YJ. · · 2019 · cited 275× · PMID 31681259 · DOI 10.3389/fimmu.2019.02250
5. Strategies in the delivery of Cas9 ribonucleoprotein for CRISPR/Cas9 genome editing.
   Zhang S, Shen J, Li D, Cheng Y. · · 2021 · cited 266× · PMID 33391496 · DOI 10.7150/thno.47007
6. CRISPR-Cas systems: Overview, innovations and applications in human disease research and gene therapy.
   Xu Y, Li Z. · · 2020 · cited 202× · PMID 33005303 · DOI 10.1016/j.csbj.2020.08.031
7. Gene editing and CRISPR in the clinic: current and future perspectives.
   Hirakawa MP, Krishnakumar R, Timlin JA, Carney JP, et al · · 2020 · cited 126× · PMID 32207531 · DOI 10.1042/bsr20200127
8. Strategies to overcome the main challenges of the use of CRISPR/Cas9 as a replacement for cancer therapy.
   Rasul MF, Hussen BM, Salihi A, Ismael BS, et al · · 2022 · cited 105× · PMID 35241090 · DOI 10.1186/s12943-021-01487-4