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Individual Patient Investigational New Drug (IND) Expanded Access Program of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Participant With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04452994
Expanded Access Status : No longer available
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this individual-patient investigational new drug (IND) single patient request (SPR) is to provide participants treatment with JNJ-68284528, an investigational product prior to its marketing authorization. Such access may be considered for participants with serious/life-threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: JNJ-68284528

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Individual Patient IND Expanded Access Program JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Patient J.M. With Multiple Myeloma

Intervention Details:
  • Drug: JNJ-68284528
    JNJ-68284528 will be administered as a single intravenous (IV). The target dose will be the recommended Phase 2 dose (RP2D) of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg) (range: 0.5 to 1.0*10^6 CAR-positive viable T cells/kg).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult

No Contacts or Locations Provided
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04452994    
Other Study ID Numbers: CR108848
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases