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Reporting Scenario # 3

Reporting Scenario # 3. September 18, 2005. Scenario # 3. Ms. Balboa, 36 yr old female with NHL. Treated with sibling donor PBPC transplant & cultured donor T-cells. Lab: 5 Validation runs show that the T-cells preferentially express certain cytokines.

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Reporting Scenario # 3

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  1. Reporting Scenario # 3 September 18, 2005

  2. Scenario # 3 • Ms. Balboa, 36 yr old female with NHL. • Treated with sibling donor PBPC transplant & cultured donor T-cells. • Lab: 5 Validation runs show that the T-cells preferentially express certain cytokines. • Due to time limitations on the day of final harvest, these cytokines are not a release specification.

  3. Scenario # 3 • Pt has disease in her abdomen and CNS. • She has fevers and is on antibiotics and antifungals. • She is thrombocytopenic (platelet count <20K/µl).

  4. Scenario # 3 • One week post infusion: • Temps spike to 40°C. • Pt has a grand mal seizure and becomes stuporous. • Head CT shows • Lymphoma lesions larger • Bleeding

  5. Scenario # 3 • Is this an adverse event? • Yes.

  6. Scenario # 3 • If an adverse event, is the event serious? Life-threatening? Unexpected? • This pt was very ill. The events are serious and life-threatening, but not unexpected. • Their causal relationship to the T-cells is questionable.

  7. Scenario # 3 • This scenario demonstrates the need to define toxicities that are expected as part of the ‘standard’ part of the protocol (PBPC transplant) versus the ‘investigational’ part of the protocol (cultured T-cells).

  8. Scenario # 3 • Is this reportable to the FDA? If so, how should it be reported? • This SAE should be reported to the IND sponsor unless it has been specifically identified in the protocol or Investigator’s Brochure as not needing reporting (for example, tumor progression) • If reportable to the IND sponsor, it should be reported to FDA, but probably not urgently, because it likely is not related to the investigational agent and it is probably not unexpected. • It would be reasonable for the IND sponsor to collate such AEs/clinical outcomes for the IND annual report.

  9. Scenario # 3 • What else should you do? • Since the events appear to be unrelated to the product, the sponsor has no further product-related responsibilities.

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