A positive cross-match exists between the donor and recipient
DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the donor should be excluded if any of the flow cytometric B and T cell cytotoxic cross match assays are positive
DONOR: A positive anti-donor cytotoxic cross match is absolute donor exclusion
HLA-MATCHED UNRELATED DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\r\n* Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\r\n* Unrelated donor:\r\n** Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\r\n** Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\r\n** Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplant (HCT); if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\r\n* Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
DONOR: HLA crossmatching (in order of priority)\r\n- 1. Mutually compatible (no cross-matching antibodies)\r\n- 2. Recipient non-cross-reactive with donor, donor cross-reactive with recipient\r\n- 3. Mutually cross-reactive
Donors: A positive anti-donor cytotoxic cross match is absolute donor exclusion
Unrelated Donor: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion; donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results
DONOR: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion; donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results
Patients must have a human leukocyte antigen (HLA)?matched related donor or an unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation, or bone marrow donation as follows:\r\n* Related donor related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\r\n* Unrelated donor: \r\n** Matched for HLA?A, B, C, DRB1 DQB1 by high resolution typing; OR\r\n** Mismatched for a single allele without antigen mismatching at HLA?A, B, or C as defined by high resolution typing but otherwise matched for HLA?A, B, C, DRB1 and DQB1 by high resolution typing\r\n** Patient and donor pairs homozygous at a mismatched allele, in the graft rejection vector are considered a two?allele mismatch, i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed\r\n* Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti?donor cytotoxic crossmatch is an absolute donor exclusion
Patients must have an human leukocyte antigen (HLA)-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation, as follows: \r\n* Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\r\n* Unrelated donor:\r\n** Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR mismatched for a single allele without antigen mismatching at HLA-A, B or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing \r\n** Doors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplant (HCT); if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with and HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\r\n** Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch; i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
DONOR: Donors who are cross-match positive with recipient
Cross-match positive with donor
UNRELATED DONORS: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody screens to class I and II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
DONOR: In case there are two or more donors with an equivalent HLA mismatch in the host-versus-graft (HVG) direction, donors will next be selected based on the most favorable combination of (i) HLA compatibility in cross-match testing and (ii) ABO compatibility:\r\n* HLA cross matching (in order of priority)\r\n1. Mutually compatible (no cross-matching antibodies)\r\n2. Recipient non-cross-reactive with donor, donor cross-reactive with recipient\r\n3. Mutually cross-reactive\r\n* ABO compatibility (in order of priority)\r\n1. Compatible\r\n2. Minor incompatibility\r\n3. Major incompatibility\r\n4. Major and minor incompatibility
Patients must be positive for at least one of the following human leukocyte antigens (HLA): a. HLA-A*02:01, b. HLA-A*02:06, c. HLA-A*24:02
Subject is HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 positive as determined by a central laboratory. (This determination will be made under a pre enrollment screening informed consent form [ICF]. There are no restrictions on the timing of HLA typing for screening and data can be taken from subjects' records).
The patient must test positive for HLA-A2 (tested by a CLIA approved laboratory; only the\r\n HLA A*02:01 subtype is eligible)
Subject is HLA-A*02:01 and/or HLA-A*02:06 positive.
Subject is HLA-A*02:05 in either allele, HLA-B*15:01 and/or HLA-B*46:01 positive. Subject has any A*02 null allele (designated with an \N\, e.g. A*02:32N) as the sole HLA-A*02 allele.
Patients must be positive for HLA-A2 based on flow­cytometry or genotyping
HLA-A*0201 (HLA-A2.1) positivity by molecular subtyping
Patients must express HLA-A*0201
HLA-A*0201 (HLA-A2.1) positivity by molecular subtyping
Patients must have the HLA-A*02:01 allele
Patients must be HLA-A*1101 positive
Subject is HLA-A*02:05 positive in either allele; Subject has HLA-A*02:07 as the sole HLA-A*02 allele (e.g., a subject with HLA alleles A*02:04 and A*02:07 is eligible); or Subject has any A*02 null allele (designated with an \N\, e.g., A*02:32N) as the sole HLA-A*02 allele
Subject is HLA-A*02:01 or HLA-A*02:06 positive.
Subject is HLA-A*02:05, HLA-B*15:01 and/or HLA-B*46:01 positive.
Must be HLA- A*02:01 positive; (retesting is not required for patients who have previous documented HLA- A*02:01 positivity)
HLA phenotype positive.
Patients must be HLA-A*0201 positive
HLA-A*02:01 expression
Lack of HLA-A*02:01 expression
Patient Human Leukocyte Antigen (HLA) typing should demonstrate HLA-A*01, and/or HLA-A*02, and/or HLA-A*24 restriction.
Patients with HLA-A alleles not belonging to any of the following subtypes: HLA-A*01, or HLA-A*02, or HLA-A*24.
Subjects must express HLA-A2 phenotype as assessed serologically.
HLA-A2 negative patients
All study participants must have one of the HLA alleles: HLA-A*02, HLA-A*03, HLAA*11, or HLA-A*24
Patients must be HLA-A*01 positive
Patients must express HLA-A*0201
HLA-A*0201 positive by Central Assay
Be HLA-A*02+ as determined by Central Laboratory;
Patient Human Leucocyte Antigen (HLA) typing should demonstrate HLA-A*01, and/or HLA-A*02, and/or HLA-A*24 restriction.
Patients without HLA-A1, or HLA-A*02, or HLA-A*24 restriction.
Subjects must be HLA-A2 positive
HLA phenotype positive. Note: Patients who were previously HLA-typed for participation in other Immatics' sponsored clinical trials and were HLA phenotype positive may enter IMA202-101 main screening
Expression of HLA-A*0201.
Expression of HLA-A*0201.
Be HLA-A2 positive
Subjects must be HLA-A2 positive by central lab
Patient is HLA-A2+
HLA-A*0201 positive as determined by deoxyribonucleic acid (DNA) allele-specific polymerase chain reaction (PCR) assay; HLA restriction is not required for cohorts 4 and 5
HLA-A*0201 positive as determined by deoxyribonucleic acid (DNA) allele-specific polymerase chain reaction (PCR) assay\r\n* For cohort 5 after amendment 9 and cohort 6, there is no HLA restriction
Subject must be HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive.
Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping\r\n* Patients with HLA-A*0205 (HLA-A2.5) positivity by molecular subtyping may be eligible if there is demonstration that they can correctly present the MART-1 26-35 epitope as stimulators for interferon (IFN)-gamma production by MART-1 F5 TCR transgenic cells
Human leukocyte antigen (HLA)-A*02, HLA-A*03, HLA-A*11 or HLA-A*24 positive patients
Must be HLA A*0201, HLA-A*0205, and/or HLA-A*0206 positive by high resolution testing.
The patient must express HLA class I allele HLA-A*0201 for NY-ESO-1/LAGE.
Blood HLA-A2 phenotype
HLA-A02*:01 positive
Patient must be HLA-A*0201+ and/or HLA-A*0206+
Subject must be HLA A*02:01, HLA A*02:05 and/or HLA-A*02:06 positive.
HLA A*0201 high resolution, 4-digit type is required at HLA-A2 to ensure A*0201 status
HLA-A2+ or HLA-A3+ or HLA-A24+ or HLA-A26+
HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by high resolution testing at a local or central laboratory
Patients must be HLA-A2 positive
HLA-A2 negative patients
HLA-A2 or HLA-A3 haplotype
HLA-DPB1*04:01 positive
Positive for HLA-A*02:01or HLA-A*02:642 allele.
Positive for any of the HLA-A*02 allele other than HLA-A*02:01 or HLA-A*02:642 or the following alleles: HLA-A*02:02, HLA-C*04:04 or HLA-B*51:03.