NCT03076437

Anti-CD19 Chimeric Antigen Receptor (CAR)-Transduced T Cell Therapy for Patients With B Cell Malignancies

Completed Phase 1, PHASE2 Last updated 19 March 2021

What this trial tests

Phase 1, PHASE2 trial testing Drugs and Anti-CD19-CAR transduced T cells in Acute Lymphocytic Leukemia in 28 participants. Completed in 31 December 2019.

Timeline

15 January 2016

Primary endpoint
26 May 2019

31 December 2019

Quick facts

Lead sponsor	Shenzhen Institute for Innovation and Translational Medicine
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	15 January 2016
Primary completion	26 May 2019
Estimated completion	31 December 2019
Sites	1 location across China

Drugs / interventions tested

• Drugs and Anti-CD19-CAR transduced T cells

Conditions studied

• Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
• Lymphoma — all drugs for Lymphoma →

Sponsor

Shenzhen Institute for Innovation and Translational Medicine

Who can join

Adults 1 to 80, any sex, with Acute Lymphocytic Leukemia or Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.

Objectives:

To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for patients with B cell malignancies.

Eligibility:

Patients between 1 and 80 years of age, who have relapsed or refractory CD19-expressing B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.

Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria are eligible to participate.

Patients must have adequate organ functions.

Design:

Peripheral blood from patients will be collected for isolation of peripheral blood mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector encoding anti-CD19 CAR containing a CD28 or 4-1BB and a CD3 zeta as costimulatory domains.

Patients will receive a lymphodepleting preconditioning regimen to prepare their immune system to accept modified T cells.

Patients will receive an infusion of their own modified T cells. They will remain in the hospital to be monitored for adverse events until they have recovered from the treatment.

Patients will have frequent follow-up visits to monitor the persistence of modified T cells and efficacy of the treatment.

Publications & conference data

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

1. Selecting costimulatory domains for chimeric antigen receptors: functional and clinical considerations.
   Weinkove R, George P, Dasyam N, McLellan AD. · · 2019 · cited 254× · PMID 31110702 · DOI 10.1002/cti2.1049
2. 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
3. CD8⁺ T cell-based cancer immunotherapy.
   Chen Y, Yu D, Qian H, Shi Y, et al · · 2024 · cited 63× · PMID 38685033 · DOI 10.1186/s12967-024-05134-6
4. 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
5. Chimeric antigen receptor-modified T cell therapy in chronic lymphocytic leukemia.
   Zou Y, Xu W, Li J. · · 2018 · cited 23× · PMID 30458878 · DOI 10.1186/s13045-018-0676-3
6. The potential of CAR T therapy for relapsed or refractory pediatric and young adult B-cell ALL.
   Forsberg MH, Das A, Saha K, Capitini CM. · · 2018 · cited 19× · PMID 30233192 · DOI 10.2147/tcrm.s146309
7. CRISPR, CAR-T, and NK: Current applications and future perspectives.
   Khoshandam M, Soltaninejad H, Hamidieh AA, Hosseinkhani S. · · 2024 · cited 11× · PMID 38545126 · DOI 10.1016/j.gendis.2023.101121
8. CAR-modified immune cells as a rapidly evolving approach in the context of cancer immunotherapies.
   Faeq MH, Al-Haideri M, Mohammad TAM, Gharebakhshi F, et al · · 2023 · cited 7× · PMID 37083979 · DOI 10.1007/s12032-023-02019-4