WithdrawnPhase 1

Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies

United States0Started 2016-07

Plain-language summary

This is an open-label, non-randomized study to evaluate the safety of two planned infusions of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with hematologic malignancies.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Signed informed consent
✓. Patients with one of the life-threatening hematological malignancies:
✓. Age ≥ 18 years and ≤ 65 years
✓. Deemed eligible for allogeneic stem cell transplantation
✓. Lack of suitable conventional donor (i.e. 8/8 related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
✓. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl loci
✓. Subjects with adequate organs function as measured by:
✓. Performance status: Karnofsky ≥ 80%

Exclusion criteria

✕. HLA 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) related or unrelated donor able to donate;
✕. Autologous hematopoietic stem cell transplant ≤ 3 months prior to enrollment;
✕. Prior allogeneic transplantation;
✕. Active CNS involvement by malignant cells (less than 2 months from the conditioning);
✕. Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings); the PI is the final arbiter of this criterion;
✕. Positive HIV serology or viral RNA (≥ Grade III per CTCAE criteria);
✕. Pregnancy (positive serum or urine βHCG test) or breast-feeding;
✕. Fertile men or women unwilling to use effective forms of birth control or abstinence for a year after transplantation;

What they're measuring

Adverse events

Timeframe: 2 years

Trial details

NCT IDNCT02487459

SponsorBellicum Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

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