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Induction of Alloantigen-specific Anergy in Human Peripheral Blood Mononuclear Cells by Alloantigen Stimulation with Co-stimulatory Signal Blockade

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Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis.

Yongxian Hu¹, Mingming Zhang¹, Tingting Yang¹

¹From the Bone Marrow Transplantation Center, First Affiliated Hospital, and Liangzhu Laboratory, Zhejiang University School of Medicine (Y.H., M.Z., T.Y., Z.M., G.W., R.J., H.Z., R.C., C.Z., T.G., P.X., R.H., J.F., S.F., D.K., H.X., J.C., S.H., X.Y., H.G., Y.F., C.J., D.W., H.H.), the Institute of Hematology (Y.H., M.Z., T.Y., Z.M., G.W., R.J., H.Z., R.C., C.Z., T.G., P.X., R.H., J.F., S.F., D.K., H.X., J.C., S.H., X.Y., H.G., Y.F., C.J., D.W., H.H.) and the Department of Epidemiology and Statistics, School of Public Health (Y.Y.), Zhejiang University, and Zhejiang Province Engineering Laboratory for Stem Cell and Immunity Therapy (Y.H., M.Z., T.Y., Z.M., G.W., R.J., H.Z., R.C., C.Z., T.G., P.X., R.H., J.F., S.F., D.K., H.X., J.C., S.H., X.Y., H.G., Y.F., C.J., D.W., H.H.), Hangzhou, the Department of Medical Oncology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (B.L.), the Department of Hematology, Beijing Tiantan Hospital, Capital Medical University, Beijing (Q.C.), Nanjing Bioheng Biotech, Nanjing (J.R.), and the Engineering Research Center of Gene Technology, Ministry of Education, Institute of Genetics, School of Life Sciences, Fudan University, and Shanghai YaKe Biotechnology, Shanghai (A.H.C.) - all in China.

The New England Journal of Medicine

|April 24, 2024

Summary

This study shows that sequential CD7 CAR T-cell therapy and haploidentical stem cell transplant is a safe and effective treatment for relapsed or refractory CD7-positive leukemias and lymphomas. This novel approach offers hope for patients ineligible for conventional transplants.

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Area of Science:

Hematology
Immunotherapy
Oncology

Background:

Relapsed or refractory hematologic cancers carry a poor prognosis.
Chimeric antigen receptor (CAR) T-cell therapy followed by allogeneic hematopoietic stem-cell transplantation (HSCT) shows potential for long-term tumor elimination.
Pre-transplant conditioning and graft-versus-host disease (GVHD) prophylaxis can negatively impact CAR T-cell function and antitumor effects.

Purpose of the Study:

To evaluate the safety and efficacy of a novel sequential CD7 CAR T-cell therapy and haploidentical HSCT strategy.
To assess the impact of this integrated approach on CAR T-cell function and tumor control in patients with relapsed or refractory CD7-positive leukemia or lymphoma.

Main Methods:

A sequential 'all-in-one' strategy involving CD7 CAR T-cell therapy followed by haploidentical HSCT was tested in 10 patients.
Patients received haploidentical HSCT without pharmacologic myeloablation or GVHD prophylaxis after achieving complete remission with incomplete hematologic recovery post-CAR T-cell therapy.
Toxic effects and efficacy were closely monitored.

Main Results:

All 10 patients achieved complete remission with incomplete hematologic recovery after CAR T-cell therapy.
Following HSCT, 8 patients achieved full donor chimerism; 3 experienced grade 2 acute GVHD.
At a median follow-up of 15.1 months, 6 patients remained in remission, with an estimated 1-year overall survival of 68% and disease-free survival of 54%.

Conclusions:

Sequential CD7 CAR T-cell therapy and haploidentical HSCT is a safe and effective strategy for CD7-positive hematologic malignancies.
This approach demonstrates feasibility and promising outcomes for patients ineligible for conventional allogeneic HSCT.
The strategy resulted in remission and manageable adverse events, suggesting its potential as a viable treatment option.