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

Withdrawn before enrolling · Phase 1

Conditions studied: Hematologic Malignancies

In brief

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.

Key facts

Study ID

NCT02487459

Run by

Bellicum Pharmaceuticals

People needed

0

Starts

2016-07-01

Expected to finish

2017-06-01

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Patients with one of the life-threatening hematological malignancies:
• Acute lymphocytic leukemia (ALL) in CR1 with high-risk features including adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or MLL gene rearrangements; greater than 1 cycle to achiever remission or with persistent MRD; ALL in second or greater remission with or without MRD. Acute myeloid leukemia (AML) in CR1 with high-risk features defined as: Greater than 1 cycle of induction therapy required to achieve remission; Preceding myelodysplastic syndrome (MDS) or myeloproliferative disease; Presence of FLT3 mutations or internal tandem duplications; FAB M6 or M7 classification; Adverse cytogenetics, -5, del 5q, -7, del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 [> 3 abnormalities];
• AML in second or greater remission, primary induction failure and patients with relapsed disease;
• Advanced chronic myeloid leukemia (CML) who have progressed to blast phase or accelerated phase and are in need of a transplant and do not have an HLA matched donor;
• MDS with IPSS intermediate-2 or higher or therapy-related MDS.Hodgkin lymphoma or Non-Hodgkin lymphoma (NHL): relapsed disease where remission duration is less than 1 year, relapse after previous autologous transplant, or failure to achieve CR with chemotherapy.
• 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
• A minimum genotypic identical haplotype match of 4/8 is required
• The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1
• Subjects with adequate organs function as measured by:
• Cardiac: Left ventricular ejection fraction at rest must be >45%
• Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); or O2 saturation > 92% on room air
• Hepatic: Direct bilirubin ≤ 3 x upper limit of normal (ULN), or AST/ALT ≤ 5 x ULN
• Renal: Serum creatinine within normal range for age or creatinine clearance, or with a recommended GFR ≥ 50 mL/min/1.73m2
• Performance status: Karnofsky ≥ 80%

You may not qualify if…

• 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;
• Bovine product allergy.
• Severe obesity (patient's weight is >/= 1.5x the donor weight).

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.