NCT03097770

Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD20

Completed Phase 1, PHASE2 Last updated 2 September 2020

What this trial tests

Phase 1, PHASE2 trial testing anti-CD19/20-CAR vector-transduced T cells in Hematopoietic/Lymphoid Cancer in 100 participants. Completed in 31 January 2020.

Timeline

1 April 2017

Primary endpoint
10 May 2019

31 January 2020

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 April 2017
Primary completion	10 May 2019
Estimated completion	31 January 2020
Sites	1 location across China

Drugs / interventions tested

• anti-CD19/20-CAR vector-transduced T cells — full drug profile →

Conditions studied

• Hematopoietic/Lymphoid Cancer — all drugs for Hematopoietic/Lymphoid Cancer →
• Adult Acute Lymphoblastic Leukemia in Remission — all drugs for Adult Acute Lymphoblastic Leukemia in Remission →
• B-cell Adult Acute Lymphoblastic Leukemia — all drugs for B-cell Adult Acute Lymphoblastic Leukemia →
• B-cell Chronic Lymphocytic Leukemia — all drugs for B-cell Chronic Lymphocytic Leukemia →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 16 to 70, any sex, with Hematopoietic/Lymphoid Cancer or Adult Acute Lymphoblastic Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.

Publications & conference data

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

1. Engineering and Design of Chimeric Antigen Receptors.
   Guedan S, Calderon H, Posey AD, Maus MV. · · 2019 · cited 339× · PMID 30666307 · DOI 10.1016/j.omtm.2018.12.009
2. Optimized tandem CD19/CD20 CAR-engineered T cells in refractory/relapsed B-cell lymphoma.
   Tong C, Zhang Y, Liu Y, Ji X, et al · · 2020 · cited 239× · PMID 32556247 · DOI 10.1182/blood.2020005278
3. Next generation chimeric antigen receptor T cells: safety strategies to overcome toxicity.
   Yu S, Yi M, Qin S, Wu K. · · 2019 · cited 208× · PMID 31429760 · DOI 10.1186/s12943-019-1057-4
4. Mechanisms of resistance to chimeric antigen receptor-T cells in haematological malignancies.
   Ruella M, Korell F, Porazzi P, Maus MV. · · 2023 · cited 123× · PMID 37907724 · DOI 10.1038/s41573-023-00807-1
5. Immunotherapy in hematologic malignancies: achievements, challenges and future prospects.
   Tang L, Huang Z, Mei H, Hu Y. · · 2023 · cited 98× · PMID 37591844 · DOI 10.1038/s41392-023-01521-5
6. Long-term activity of tandem CD19/CD20 CAR therapy in refractory/relapsed B-cell lymphoma: a single-arm, phase 1-2 trial.
   Zhang Y, Wang Y, Liu Y, Tong C, et al · · 2022 · cited 88× · PMID 34272481 · DOI 10.1038/s41375-021-01345-8
7. A deep insight into CRISPR/Cas9 application in CAR-T cell-based tumor immunotherapies.
   Razeghian E, Nasution MKM, Rahman HS, Gardanova ZR, et al · · 2021 · cited 80× · PMID 34321099 · DOI 10.1186/s13287-021-02510-7
8. Clinical trials of CAR-T cells in China.
   Liu B, Song Y, Liu D. · · 2017 · cited 55× · PMID 29058636 · DOI 10.1186/s13045-017-0535-7