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A Phase I, Single-Center, Open-Label, Dose-Escalation Clinical Trial to Assess the Safety and Tolerability of an Intranasal Memory T Lymphocytes Solution in Adult Females: vRELEASE I. (vRELEASE I)

C

Cristina Calvo Rey

Status and phase

Not yet enrolling
Phase 1

Conditions

To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte Solution

Treatments

Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.

Study type

Interventional

Funder types

Other

Identifiers

NCT06699758
HULP: 6796

Details and patient eligibility

About

Proof-of-concept trial to assess the safety and tolerability of intranasal administration of a male donor memory T lymphocyte solution in females aged between 18 - 55 years of age.

Enrollment

9 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female subjects between 18 - 55 years of age.
  • Participants are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Patients with the ability to comprehend and sign the informed consent.
  • Written informed consent obtained prior to any screening procedures.
  • Subjects in good health with no baseline disease of any kind.

Exclusion criteria

  • Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
  • Participants who are currently under medical follow-up for any medical condition or who are regularly taking medication for any condition.
  • Subject has experienced symptoms consistent with a respiratory infection within the 7 days prior to the administration of the investigational treatment.
  • Have a known history of human immunodeficiency virus infection, Hepatitis B or Hepatitis C; testing is not required in the absence of prior documentation or known history.
  • Have a known history of drug substance abuse.
  • Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
  • Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.
  • Any condition or situation precluding or interfering with the compliance with the protocol.
  • Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

9 participants in 3 patient groups

Intervention arm Group 1
Experimental group
Description:
Administration of a total of 3x106 cells administered over three 1x106cell doses.
Treatment:
Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.
Intervention arm Group 2
Experimental group
Description:
Administration of a total of 15x106 cells administered over three 5x106cell doses.
Treatment:
Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.
Intervention arm Group 3
Experimental group
Description:
Administration of a total of cumulative 30x106 cells administered over three 10x106cell doses.
Treatment:
Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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