Safety and Efficacy of CD207 Targeted CAR-T Cell Therapy in Patients With R/R Langerhans Cell Histiocytosis

Launched by BEIJING FRIENDSHIP HOSPITAL · Jul 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD207 targeted CAR-T cell therapy for patients with relapsed or refractory Langerhans Cell Histiocytosis (LCH), a rare condition where the body’s immune system creates too many Langerhans cells, which can harm organs. The goal is to see how safe and effective this therapy is for people who have not responded well to standard treatments. The trial is currently not recruiting participants, but it aims to include individuals aged 3 to 65 years who have experienced a relapse of their condition or did not respond to previous treatments.

To be eligible for this trial, participants must have a confirmed diagnosis of LCH and meet certain health criteria, such as having a life expectancy of at least three months and specific blood test results. Participants will undergo monitoring and follow-up visits as part of the study. It’s important to note that certain individuals, such as those with active infections or severe health issues, may not be able to participate. Overall, this trial is an opportunity for eligible patients to potentially access a new form of treatment that could help manage their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Relapsed or refractory langerhans cell histiocytosis, defined as: 1) any relapse during standard chemotherapy; 2) not responding to standard chemotherapy; 3) not achieving CR after first cycle of second-line chemotherapy for relapsed langerhans cell histiocytosis;
• • 2. 3-65 years old;
• • 3. Expected survival time ≥ 3 months;
• • 4. ECOG performance status of 0 or 1 (age ≥ 16 years) or Karnofsky performance status\> 80 (age \< 16 years) ;
• • 5. With single or venous blood collection standards, and no other cell collection contraindications;
• • 6. WBC ≥ 2.5×10\^9/L ，LY ≥ 0.7×10\^9/L，LY% ≥15%;
• • 7. Serum creatinine ≤ 2.0 mg/dl;
• • 8. ALT/AST ≤ 2.5 x ULN;
• • 9. Total bilirubin ≤ 2.0 mg/dl;
• • 10. PT:INR\<1.7, or PT is within 4s of the normal value;
• • 11. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
• Exclusion Criteria:
• • 1. Transduced CAR+ T lymphocytes\<5%, or expansion \<5 folds after stimulation with anti CD3/anti CD28 beads;
• • 2. Pregnant or breasting-feeding women;
• • 3. Active hepatitis B or hepatitis C infection;
• • 4. Patients with HIV infection;
• • 5. Uncontrolled active infection;
• • 6. Use of systemic corticosteroid therapy;
• • 7. Have received gene therapy, or any other CAR-T treatment;
• • 8. Allergic to immunotherapy and related drugs;
• • 9. History of heart disease requiring treatment, or poorly controlled hypertension;
• • 10. Preceding and/or ongoing active ulcer or gastrointestinal bleeding;
• • 11. Have received allogeneic hematopoietic stem cell transplantation, or eligible for allogeneic hematopoietic stem cell transplantation;
• • 12. Severe central nervous system involvement;
• • 13. Severe lung involvement;
• • 14. Hyponatremia (serum sodium\<125mmol/L);
• • 15. Hypokalemia (Serum kalium\<3.5mmol/L);
• • 16. Those who need long-term anticoagulation treatment (warfarin or heparin);
• • 17. Those who need long-term antiplatelet treatment (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d);
• • 18. Radiation therapy within 4 weeks prior to registration;
• • 19. Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina, cardiac arrhythmias, mental illness, and other diseases that in the opinion of the investigator would pose an unacceptable risk to the subject;
• • 20. Have a history of severe allergy;
• • 21. Current enrollment in another study;
• • 22. Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement).