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

Study Purpose

This is a single-arm study to evaluate the efficacy and safety of CD207 targeted CAR-T cell therapy in relapsed and refractory langerhans cell histiocytosis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05477446
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Friendship Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	ZHAO Wang, MD
Principal Investigator Affiliation	Beijing Friendship Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Langerhans Cell Histiocytosis

Additional Details

There are limited options for treatment of r/r langerhans cell histiocytosis. CD207 is expressed on the membrane surface of langerhans cells，and it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CD207 targeted CAR- T cell therapy in patients with r/r langerhans cell histiocytosis. The primary goal is safety and efficiency assessment, including incidence and severity of adverse events and overall response rate.

Arms & Interventions

Arms

Experimental: CD207 CAR-T cells

Cohort 1 will receive 1 x 10^6 CAR+ T cells/kg. Cohort 2 will receive 3 x 10^6 CAR+ T cells/kg. Cohort 3 will receive 5 x 10^6 CAR+ T cells/kg. Cohort 4 will receive 1 x 10^7 CAR+ T cells/kg.

Interventions

Biological: - CD207 CAR-T cells

Single dose of CD207 CAR-T cells administered IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.