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Poster session 11

642P - A phase I dose escalation study of GCC19CART: A novel CoupledCAR therapy for subjects with metastatic colorectal cancer

Date

21 Oct 2023

Session

Poster session 11

Topics

Tumour Site

Colon and Rectal Cancer

Presenters

Jiuwei Cui

Citation

Annals of Oncology (2023) 34 (suppl_2): S410-S457. 10.1016/S0923-7534(23)01935-X

Authors

J. Cui1, N. Chen2, C. Pu3, L. Zhao2, N. Li4, C. Wang1, Y. Huang5, S. Luo6, X. Li7, Z. Yang8, J. Bie9, R. Zhu3, H. Tang10, T. Liang2, Y. Wang2, V. Lu11, Z. Wu3, Y. Song12, L. Xiao13

Author affiliations

  • 1 Oncology Center, The First Hospital of Jilin University, 130021 - Changchun/CN
  • 2 Oncology Center, the First Bethune Hospital of Jilin University, Changchun, Changchun/CN
  • 3 R&d, Innovative Cellular Therapeutics (ICT), Shanghai/CN
  • 4 Medical Oncology, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, 450008 - Zhengzhou/CN
  • 5 Oncology Center, The Second Affiliated Hospital of Chongqing Medical University, 402284 - Chongqing/CN
  • 6 Oncology Center, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, 450008 - Zhengzhou/CN
  • 7 Oncology Center, The First Hospital of Lanzhou University/The First School of Clinical Medicine, 730000 - Lanzhou/CN
  • 8 Oncology Center, Chongqing Medical University, 400016 - Chongqing/CN
  • 9 Oncology Center, Nanchong Central Hospital, 637000 - Nanchong/CN
  • 10 M&f, Innovative Cellular Therapeutics (ICT), Shanghai/CN
  • 11 Qa, Innovative Cellular Therapeutics Inc, Rockville/US
  • 12 Oncology Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, 450008 - Zhengzhou/CN
  • 13 Oncology Center, Innovative Cellular Therapeutics Inc, 130021 - Rockville/US

Resources

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Abstract 642P

Background

GCC19CART, the first clinical candidate from the CoupledCAR® solid tumor platform, targets guanylate cyclase-C (GCC) which is expressed in colorectal cancers. CoupledCAR utilizes multiple vectors to make both solid tumor targeting CAR-T and CD19 CAR-T in a single manufacturing step. An investigator-initiated dose escalation trial in China for patients with relapsed or refractory metastatic colorectal cancer (R/R mCRC) is reported here.

Methods

Based on a data cutoff of October 20, 2022, 21 subjects have been enrolled and treated, with all subjects completing ≥1 evaluation of response and being evaluable. Eligible subjects undergo leukapheresis, a single dose of lymphodepleting chemotherapy (fludarabine 30mg/m2 and cyclophosphamide 300mg/m2) 3 days prior to infusion, and then administration of a single infusion of GCC19CART at one of two preassigned doses: Dose 1 (1x106) or Dose 2 (2x106) CAR T-cells/kg. Endpoints are safety and preliminary evidence of efficacy.

Results

13 subjects have been enrolled to dose level 1 (1x106 cells/kg) and 8 subjects have been enrolled to dose level 2 (2x106 cells/kg). The most common adverse events were cytokine release syndrome (CRS) in 21/21 subjects (Grade 1 19/21 (90.48%) or Grade 2 2/21 (9.52%)) and diarrhea in 21/21 subjects (Grade 1 6/21 (28.57%) Grade 2 5/21 (23.81%) Grade 3 9/21 (42.86%) or Grade 4 1/21 (4.76%)). All patients with grade 3 and higher side effects were well managed. Immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in 2/21 (9.52%) subjects at Grade 3 or 4 and resolved with corticosteroids. For dose level 1, the overall response rate (ORR) per RECIST 1.1 was 15.4% (2/13). The median PFS was 2.0 months and the median overall survival was also 13.3 months. For dose level 2, The ORR per RECIST 1.1 was 50% (4/8). The median PFS was 6.3 months and the median follow-up was also 21.3 months.

Conclusions

Preliminary results demonstrate that GCC19CART has meaningful dose-dependent clinical activity and an acceptable safety profile in relapsed or refractory metastatic colorectal cancer. This trial is ongoing and updated data will be presented. A phase 1 trial of GCC19CART in the US has opened for accrual and is expected to enroll patients in mid-2022.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Innovative Cellular Therapeutics.

Funding

Innovative Cellular Therapeutics.

Disclosure

L. Xiao: Financial Interests, Personal and Institutional, Other, Stock holders: Innovative Cellular Therapeutics. All other authors have declared no conflicts of interest.

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