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Eligibility

Eligible Ages

Over 15 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Eligible participants are HIV positive and plan to be treated by high dose chemotherapy
followed by an autologous stem cell transplant (ASCT). Participants are a minimum of 15
years of age with Karnofsky performance status greater than or equal to 70% that have
primary refractory or recurrent diffuse large B-cell, immunoblastic, plasmablastic, high
grade, Burkitt, primary effusion lymphoma, or classical Hodgkin lymphoma. Participants must
have chemosensitive disease as demonstrated by complete or partial response to induction or
most recent salvage chemotherapy. Participants cannot have had prior autologous, allogeneic
HCT, or CART-cell therapy. Participants must initiate conditioning therapy within 3 months
of stem cell mobilization or bone marrow harvest. Blood cell mobilization or bone marrow
harvest will be carried out per institutional guidelines. Participants may not have HIV
refractory to pharmacologic therapy. Patients must not have an uncontrolled infection.
Participants must not have received previous cellular therapy

1. Age 15 years old or older at time of enrollment.

2. Receiving antiretroviral therapies (ART) with HIV viral load < 200 copies or below the
limit of detection by standard commercial assay. An HIV-1 RNA measurement that is ≥
200 copies measured by an FDA-approved commercial assay but <500 copies may be allowed
if this is followed by an HIV-1 RNA measurement below the limit of detection or if an
exception is approved.

3. Diagnosis of refractory or recurrent diffuse large B-cell lymphoma, composite lymphoma
with greater than 50% diffuse large B-cell lymphoma, mediastinal B-cell lymphoma,
immunoblastic, plasmablastic, Burkitt or high grade B cell lymphoma or classical
Hodgkin lymphoma. Participants with aggressive B-cell lymphoma that is transformed
from follicular lymphoma are eligible for the study, pending fulfillment of other
criteria.

4. Plan to treat participant with high dose chemotherapy and autologous hematopoietic
stem cell transplantation (ASCT).

5. All participants must have chemosensitive disease as demonstrated by at least a
partial response (as defined by the criteria in Chapter 3) to induction or salvage
therapy.

6. Absolute Lymphocyte Count (ALC) greater than or equal to 800/µL. If ALC is less than
800/uL but still above 400/uL patient may be eligible if the HST-NEETs manufacturing
blood product is collected via non-mobilized leukapheresis(apheresis).

7. Participants with adequate organ function as measured by:

1. Cardiac: Participants must have a left ventricular ejection fraction at rest
greater than or equal to 40% demonstrated by MUGA or echocardiogram.

2. Hepatic:

i. Bilirubin less than or equal to 2.0 mg/dL (except for isolated hyperbilirubinemia
attributed to Gilbert syndrome or antiretroviral therapy as specified in Appendix D)
and ALT and AST less than or equal to 3x the upper limit of normal. ii. Concomitant
Hepatitis: Participants with chronic hepatitis B or C may be enrolled on the trial
providing the above criteria are met. In addition, they must not have evidence of
active viral replication by PCR, and no clinical or pathologic evidence of
irreversible chronic liver disease. c) Renal: Creatinine clearance (calculated
creatinine clearance is permitted based on institutional practice) greater than 40
mL/min.

d) Pulmonary DLCO (corrected for hemoglobin), FEV1, FVC greater than or equal to 45%
of predicted.

8. Voluntary written consent or assent obtained prior to enrollment on study with the
understanding that consent or assent may be withdrawn by the participant at any time
without prejudice to future medical care.

Exclusion Criteria:

1. Karnofsky performance score less than 70%.

2. Participant is known to have an HIV subtype other than B.

3. Participant has documented raltegravir or protease inhibitor resistance.

4. Myocardial infarction within 6 months prior to enrollment or New York Heart
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia.

5. Uncontrolled bacterial, viral or fungal infection (currently taking medication and
with progression or no clinical improvement).

6. Participant has active CNS involvement.

7. Participants with prior malignancies except resected non-melanoma skin cancer or
treated cervical carcinoma in situ. Cancer treated with curative intent greater than
or equal to 5 years previously will be allowed. Cancer treated with curative intent
less than 5 years BMT CLINICAL TRIALS NETWORK HIV T-Cell - Protocol 1903 Version 1.0
Dated February 24, 2021 2-4 Confidential previously may be eligible must be reviewed
and approved by the Protocol Officer or Chairs.

8. Female participants that are pregnant as per institutional definition or
breastfeeding.

9. Fertile men or women unwilling to use contraceptive techniques from the time of
initiation of mobilization until six-months post-transplant.

10. Prior autologous or allogeneic HCT, or prior therapy with chimeric antigen receptor
(CAR) T-cells.

11. Participants with evidence of MDS/AML or abnormal cytogenetic analysis indicative of
MDS on the pre-transplant bone marrow examination. Pathology report documentation need
not be submitted.

12. Steroids greater than 0.5 mg/kg/day prednisone equivalents.

13. Bone marrow involvement by lymphoma at time of workup. Prior history of bone marrow
involvement is allowed if cleared prior to ASCT.