Drugs / CD19 CAR-T
last change Mar 2026 re-read 9 days ago

CD19 CAR-T

Cell therapy targets CD19

Developed for
autoimmune disease · B-cell acute lymphoblastic leukemia · acute lymphoblastic leukemia · B-cell non-Hodgkin lymphoma · non-Hodgkin lymphoma · acute leukemia · B-cell adult acute lymphocytic leukemia · B-cell neoplasm
+8 more · childhood acute lymphoblastic leukemia · follicular lymphoma · lupus nephritis · lymphoid leukemia · lymphoma · mantle cell lymphoma · plasma cell myeloma · therapy-related myeloid neoplasm
Investigated by
Hebei Senlang Biotechnology Inc., Ltd. · Beijing Boren Hospital · Bioray Laboratories · Chinese PLA General Hospital · Shenzhen University General Hospital · Beijing Lu Daopei Hospital
+21 more · Gracell Biotechnology Ltd. · Hebei Taihe Chunyu Biotechnology Co., Ltd · Hebei Yanda Ludaopei Hospital · Henan Cancer Hospital · Innovative Cellular Therapeutics Co., Ltd. · Institute of Hematology & Blood Diseases Hospital, China · Jichi Medical University · Nanfang Hospital, Southern Medical University · PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Second Affiliated Hospital of Suzhou University · Second Affiliated Hospital, School of Medicine, Zhejiang University · Second Xiangya Hospital of Central South University · Shanghai Tong Ren Hospital · Shenzhen Second People's Hospital · Shenzhen University · Takara Bio Inc. · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The Beijing Pregene Science and Technology Company, Ltd. · The Pregene (ShenZhen) Biotechnology Company, Ltd. · The Second Hospital of Hebei Medical University · Zhujiang Hospital

Trials 21

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 08 trials
Phase 0 NCT07435779 Feb 2026 → Feb 2027 expected — Hebei Senlang Biotechnology Inc., Ltd. Recruiting No outcome recorded
Phase 0 NCT06681337 Nov 2024 → Dec 2025 overdue lupus nephritis Bioray Laboratories Not yet recruiting No outcome recorded
Phase 0 NCT06680388 Nov 2024 → Dec 2027 expected autoimmune disease Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 0 NCT04626739 Apr 2020 → Mar 2023 non-Hodgkin lymphoma Hebei Senlang Biotechnology Inc., Ltd. Unknown No outcome recorded
Phase 0 NCT04626726 Apr 2020 → May 2023 B-cell adult acute lymphocytic leukemia Hebei Senlang Biotechnology Inc., Ltd. Unknown No outcome recorded
Phase 0 NCT04626765 Apr 2020 → Mar 2023 childhood acute lymphoblastic leukemia Hebei Senlang Biotechnology Inc., Ltd. Unknown No outcome recorded
Phase 0 NCT04184414 Jan 2018 → Jan 2020 B-cell acute lymphoblastic leukemia, follicular lymphoma, mantle cell lymphoma PersonGen BioTherapeutics (Suzhou) Co., Ltd. Unknown No outcome recorded
Phase 0 NCT03407859 Jan 2016 → Dec 2024 therapy-related myeloid neoplasm Zhujiang Hospital Unknown No outcome recorded
Phase 14 trials
Phase 1 NCT05585996 Aug 2022 → Nov 2025 B-cell non-Hodgkin lymphoma Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
Phase 1 NCT04012879 May 2019 → Apr 2021 acute lymphoblastic leukemia Chinese PLA General Hospital Unknown No outcome recorded
Phase 1 NCT04012892 May 2019 → Apr 2021 non-Hodgkin lymphoma Chinese PLA General Hospital Unknown No outcome recorded
Phase 1 NCT03559439 Apr 2018 → Nov 2021 B-cell acute lymphoblastic leukemia Shanghai Tong Ren Hospital Unknown No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT03232619 Aug 2018 → May 2020 acute leukemia Bioray Laboratories Completed No outcome recorded
Phase 1/2 NCT03263208 Aug 2017 → Jan 2019 B-cell acute lymphoblastic leukemia Henan Cancer Hospital Unknown No outcome recorded
Phase 1/2 NCT03146533 May 2017 → Apr 2019 B-cell neoplasm Shenzhen Second People's Hospital Unknown No outcome recorded
Phase 1/2 NCT02134262 May 2014 → Mar 2017 B-cell non-Hodgkin lymphoma Jichi Medical University Unknown No outcome recorded
Phase not applicable5 trials
— NCT06983964 Feb 2025 → Feb 2027 expected autoimmune disease Beijing Boren Hospital Recruiting No outcome recorded
— NCT06993493 Feb 2025 → Aug 2027 expected autoimmune disease Beijing Boren Hospital Recruiting No outcome recorded
— NCT05618041 Sep 2022 → Sep 2027 expected acute lymphoblastic leukemia, plasma cell myeloma Hebei Senlang Biotechnology Inc., Ltd. Recruiting No outcome recorded
— NCT04546893 Sep 2020 → Sep 2022 — Hebei Senlang Biotechnology Inc., Ltd. Unknown No outcome recorded
— NCT02813837 Jun 2015 → Jan 2021 lymphoid leukemia, lymphoma Innovative Cellular Therapeutics Co., Ltd. Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2026-03-16 HCW Biologics Results HCW Biologics Announces Positive Research Results for CAR-T Cell Therapy Manufactured Utilizing Its Commercial-Ready Proprietary Compound, HCW9206, Published in Science Advances hcwbiologics.com ↗
In experimental models, human CAR-T cells manufactured using HCW9206 showed strong anti-tumor activity in leukemia and enhanced antiviral potency in HIV suggesting potential for curative outcomes
2025-10-25 Novartis Pharmaceuticals Results Novartis showcases significant immunology advancements in ACR congress with new data in complex autoimmune diseases novartis.com ↗
Biomarker data from an open-label, Phase 1/2 Study for YTB323 (Rapcabtagene Autoleucel, a rapidly manufactured CD19 CAR-T therapy) suggest reset of the B Cell compartment in severe refractory SLE
2022-01-18 CASI pharmaceuticals, Inc. Regulatory CASI PHARMACEUTICALS ANNOUNCES CNCT19 (CD19 CAR-T) GRANTED ORPHAN DRUG DESIGNATION BY THE U.S. FDA issuerdirect.com ↗
2020-12-23 CASI pharmaceuticals, Inc. Regulatory CASI Pharmaceuticals Announces CNCT19 (CD19 CAR-T) Receives China Breakthrough Therapy Designation issuerdirect.com ↗
The Breakthrough Designation for CNCT19 was granted based on initial data from the ongoing single arm, open-label, non-randomized, dose-escalation, Phase I study designed to determine the safety and efficacy of CNCT19 in B-ALL.
2019-12-03 CASI pharmaceuticals, Inc. Regulatory CASI Pharmaceuticals Announces China NMPA Approval Of CNCT19 (CD19 CAR-T) Clinical Trial Applications issuerdirect.com ↗
CASI Pharmaceuticals Announces China NMPA Approval Of CNCT19 (CD19 CAR-T) Clinical Trial Applications
2019-09-16 CASI pharmaceuticals, Inc. Regulatory China NMPA Accepts Clinical Trial Application For CASI's CD19 CAR-T-Product issuerdirect.com ↗
2019-09-11 Gracell Biotechnologies (Shanghai) Co., Ltd. Results Gracell Announces Interim Readout of Investigation for First-in-class FasT CAR-19 in patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Extension in Use of FasT CAR to Other Immune Cell Programs gracellbio.com ↗
The study shows a high response rate, with 23 of 24 treated patients achieving complete remission and 21 of 24 treated patients achieving undetectable minimal residual disease on 28 days of follow-up
2019-06-20 Gracell Biotechnologies (Shanghai) Co., Ltd. Results Gracell Data on Multi-center Investigation of FasT CAR-19 Therapy Shows Positive First Impact in Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia gracellbio.com ↗
The customized treatment which genetically modifies patient"s T-cells to express CD19-specific chimeric antigen receptor (CAR), showed a clinically meaningful and positive result in the treatment of B-cell acute lymphoblastic leukemia (B-ALL).

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as CD19 CAR-T “This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases.” NCT06983964 ↗
21

“Anti-CD19 CAR expressing T cells (CD19-CAR-T) will be expanded using a medium containing autologous plasma.” NCT02134262 ↗

“Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment in Relapsed/Refractory B-ALL” NCT03407859 ↗

“CD19 CAR-T” NCT05618041 ↗

NCT04184414 ↗

NCT03263208 ↗

NCT03232619 ↗

NCT05585996 ↗

NCT06983964 ↗

NCT04012892 ↗

NCT04626726 ↗

Show 11 more sources

Known as Anti-CD19 CAR expressing T cells “Anti-CD19 CAR expressing T cells (CD19-CAR-T) will be expanded using a medium containing autologous plasma.” NCT02134262 ↗
Action Deplete “This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process” NCT03232619 ↗
Modality Cell therapy “autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor” NCT02134262 ↗
Route Intravenous “infusions of CD19CART cells into the vein” NCT02813837 ↗
Target CD19 “CD19 targeted chimeric antigen receptor T cells therapy” NCT02813837 ↗