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Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors

P

Peking University

Status and phase

Enrolling
Phase 1

Conditions

Gastroesophageal Junction Adenocarcinoma
Pancreatic Cancer
Gastric Adenocarcinoma

Treatments

Drug: CT048 Autologous Injection (CT048)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05393986
CT048-CG4001

Details and patient eligibility

About

An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors

Full description

This is an open-label, single-arm, dose-escalation and dose-expansion, single/multiple infusion(s) exploratory study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of CT048 in patients with advanced CLDN18.2+ solid tumors who had failed to at least 1 prior line of treatment.

Enrollment

63 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Aged 18 to 75 years, male or female;
  2. Estimated life expectancy > 12 weeks;
  3. Pathologically/histologically confirmed diagnosis of advanced G/GEJ adenocarcinoma or pancreatic cancer or other digestive system malignancies G/GEJA: refractory to or intolerable of at least 2 prior lines of treatment; HER2+ subjects must be refractory or intolerable of anti-HER2 treatment PC: refractory to or intolerable of at least 1 prior line of treatment;
  4. Positive expression of CLDN18.2 in tumor tissue specimens;
  5. According to the RECIST 1.1, there is measurable or unmeasurable tumor lesions;
  6. ECOG physical status score 0 ~ 1 at screening, within 24 hours prior to apheresis;
  7. Sufficient venous access for leukapheresis (central venous catheter)
  8. Subjects should have adequate organ functions before screening :
  9. Women of childbearing age (WOCB) be willing to use effective and reliable method of contraception (annual failure<1%) for at least 1 year after last infusion, and must refrain from donating sperms/eggs
  10. Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy. Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last infusion.

Exclusion criteria

  1. High risks that may cause bleeding or perforation;
  2. CNS metastasis, with or without related symptoms;
  3. The presence of extensive lung metastases, or extensive liver metastases, or extensive bone metastases
  4. History or current unstable or active digestive ulcers, gastrointestinal (GI) bleeding, GI obstruction;
  5. Anti-tumor treatment for the investigational disease; treatment with anti-PD-1/PD-L1, anti-CTLA4, and any other immunotherapy or investigational therapy;
  6. Prior treatment with any genetically modified cell therapy;
  7. Treatment with systemic corticosteroids within 7 days prior to leukapheresis;
  8. Prior solid organ transplantation, or allogeneic stem cell, or in the waiting list for organ transplantation;
  9. Major surgical procedure or serious wound within 4 weeks prior to leukapheresis, or anticipation of need for a major surgical procedure during the study;
  10. Positive serological tests of HIV, syphilis or HCV (subjects with positive HCV antibody but are negative for HCV RNA are eligible);
  11. Any active or severe infection, incl. but not limited to active tuberculosis, HBV infection, etc.;
  12. Active autoimmune disease;
  13. Uncontrolled significant cardiovascular disease, pulmonary disease or CNS disease
  14. History of malignancy other than investigational diseases within 3 years, with the exception of malignancies with a negligible risk of metastasis or death;
  15. Pregnancy or lactating women;
  16. History of allergic anaphylactic reactions to immunotherapy, and/or tocilizumab, cyclophosphamide, fludarabine or nab-paclitaxel, and/or CT048 components, or other history of severe allergic anaphylactic reactions ;
  17. Blood oxygen saturation ≤95% before leukapheresis;
  18. AEs from previous treatment that have not recovered to CTCAE ≤ grade 1, excluding hair loss, pigmentation, and other tolerable events and laboratory abnormalities permitted by the protocol;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

63 participants in 1 patient group

Experimental: CAR-CLDN18.2 T-Cells (CT048)
Experimental group
Description:
The subjects will be initially enrolled in the lymphodepletion cohort. Subsequent subjects will be enrolled in the non-lymphodepletion cohort after reviewing the data in the lymphodepletion cohort.
Treatment:
Drug: CT048 Autologous Injection (CT048)

Trial contacts and locations

1

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Central trial contact

lin Shen, MD,phD; Changsong Qi, MD, PhD

Data sourced from clinicaltrials.gov

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